{ "name": "FDA drug recall records for GLP-1 and peptide products", "description": "Every recall record FDA’s enforcement database holds for these compounds. Each row shows the hazard class, process status, recalling firm and FDA’s stated reason.", "author": "HealthspanLedger", "edition": "2026.08", "version": "33d460f14b0e", "page": "https://healthspanledger.com/compounded/supply-chain", "citeAs": "HealthspanLedger. FDA drug recall records for GLP-1 and peptide products. Edition 2026.08 (version 33d460f14b0e). Derived from openFDA drug enforcement (recall) database, retrieved 2026-08-17. Licensed CC BY 4.0. https://healthspanledger.com/compounded/supply-chain", "license": { "url": "https://creativecommons.org/licenses/by/4.0/", "name": "Creative Commons Attribution 4.0 International (CC BY 4.0)" }, "source": { "name": "openFDA drug enforcement (recall) database", "url": "https://api.fda.gov/drug/enforcement.json", "retrieved": "2026-08-17", "publisherLastUpdated": "2026-08-05", "license": "https://open.fda.gov/license/", "licenseName": "US Government work, public domain" }, "arrangement": "The underlying records are United States government work and carry no copyright. How this table selects, joins, labels and bounds them is ours, and that work is licensed CC BY 4.0 (https://creativecommons.org/licenses/by/4.0/): reuse it, including commercially, and credit HealthspanLedger with a link to the page it came from.", "temporalCoverage": "2012/2026", "measurementTechnique": "One search per compound against product_description, the free-text field the recalling firm filled in. Results are joined on FDA’s recall number so one event that names multiple tracked compounds remains one row with every matching search preserved. FDA’s harmonized brand fields are not searched at all, because they are empty on compounded preparations and wrong when populated. Every tally is computed from the rows rather than from a server-side count.", "readThisFirst": [ "A recall record is about a firm and a lot, not about a molecule.", "One FDA recall number appears once. matched_search_terms preserves every tracked search that returned that event.", "classification is severity. status is only how far FDA has got. They are not the same column and neither ranks the other.", "A zero here is an answer, not reassurance: it means no recall has been filed and published under the names searched.", "Comparing two firms’ record counts does not say which is safer. A firm that files is a firm that noticed." ], "rows": [ { "matched_search_terms": "Liraglutide", "matched_compound_slugs": "liraglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0541-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Lupin Pharmaceuticals Inc.", "state": "FL", "product_description": "Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02; b) 3 Pens - NDC 70748-346-03.", "reason_for_recall": "Presence of particulate matter: a white thread-like structure in the cartridge", "code_info": "Lots: a) WB00097, WB00094, WB00088, Expires: Jul. 2027; WB00103, Expires: Oct. 2027; WC00016, Expires: Dec. 2027; b) WB00098, WB00092, WB00093, Expires: Jul. 2027; WB00104, WB00106, WB00105, Expires: Oct. 2027.", "product_quantity": "217,621 pen injectors", "distribution_pattern": "Nationwide within U.S", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2026-04-24", "center_classification_date": "2026-05-19", "report_date": "2026-05-27", "fda_matched_an_approved_listing": true }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0471-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "PAYLESS COMPOUNDERS, LLC", "state": "OR", "product_description": "Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beaverton, OR", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot Number 01-27-2026@14S.5", "product_quantity": "91 vials", "distribution_pattern": "OR", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2026-03-06", "center_classification_date": "2026-04-13", "report_date": "2026-04-22", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0379-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Harbin Jixianglong Biotech Co., Ltd.", "state": "N/A", "product_description": "Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04 Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China", "reason_for_recall": "CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution", "code_info": "Lot #: CP-030-20250711, Exp. Date Jul. 24th, 2027", "product_quantity": "N/A", "distribution_pattern": "Nationwide within the United States", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2026-02-13", "center_classification_date": "2026-03-02", "report_date": "2026-03-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0380-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Harbin Jixianglong Biotech Co., Ltd.", "state": "N/A", "product_description": "Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China.", "reason_for_recall": "CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution", "code_info": "Batch # CP-030-20250911, Mfg Date: Sep. 25th, 2025, Retest Date: Sep. 24th, 2027.", "product_quantity": "N/A", "distribution_pattern": "Nationwide within the United States", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2026-02-13", "center_classification_date": "2026-03-02", "report_date": "2026-03-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0392-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "New Life Pharma LLC", "state": "NJ", "product_description": "Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-07.", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot 241113, Exp Date 11/30/2026 & Lot 250103, Exp Date 1/31/2027", "product_quantity": "820 vials", "distribution_pattern": "OH", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2026-02-26", "center_classification_date": "2026-03-17", "report_date": "2026-03-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0393-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "New Life Pharma LLC", "state": "NJ", "product_description": "Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-06", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot 240903, exp 9/30/2026", "product_quantity": "2 vials", "distribution_pattern": "OH", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2026-02-26", "center_classification_date": "2026-03-17", "report_date": "2026-03-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Tirzepatide", "matched_compound_slugs": "tirzepatide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0394-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "New Life Pharma LLC", "state": "NJ", "product_description": "Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-03.", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot 240709, exp 7/31/2026", "product_quantity": "23 vials", "distribution_pattern": "OH", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2026-02-26", "center_classification_date": "2026-03-17", "report_date": "2026-03-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Tirzepatide", "matched_compound_slugs": "tirzepatide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0395-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "New Life Pharma LLC", "state": "NJ", "product_description": "Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04.", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot 240709, exp 7/31/2026", "product_quantity": "45 vials", "distribution_pattern": "OH", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2026-02-26", "center_classification_date": "2026-03-17", "report_date": "2026-03-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0244-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Novo Nordisk Inc.", "state": "NJ", "product_description": "Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4505-14", "reason_for_recall": "Presence of Particulate Matter: Hair was found in a prefilled syringe", "code_info": "Lot #: RZFHD52, RZFHW93; Exp Date 10/31/2026", "product_quantity": "N/A", "distribution_pattern": "Nationwide within the United States.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-12-19", "center_classification_date": "2025-12-31", "report_date": "2026-01-07", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0245-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Novo Nordisk Inc.", "state": "NJ", "product_description": "Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4501-14", "reason_for_recall": "Presence of Particulate Matter: Hair was found in a prefilled syringe", "code_info": "Lot #: RZFYK06, RZFYA53; Exp Date 3/31/2027", "product_quantity": "N/A", "distribution_pattern": "Nationwide within the United States.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-12-19", "center_classification_date": "2025-12-31", "report_date": "2026-01-07", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0114-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "ProRx LLC", "state": "PA", "product_description": "Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot# Prorx04282025-3", "product_quantity": "2,809 vials", "distribution_pattern": "TX and UT", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-10-15", "center_classification_date": "2025-10-27", "report_date": "2025-11-05", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0115-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "ProRx LLC", "state": "PA", "product_description": "Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-04", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot, Best Use Date (BUD): Lot PRORX050925-1, BUD November 4, 2025; Lot ProRx051425-5, BUD November 10, 2025; Lot ProRx051425-6, BUD November 10, 2025", "product_quantity": "8,400 vials", "distribution_pattern": "TX and UT", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-10-15", "center_classification_date": "2025-10-27", "report_date": "2025-11-05", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0116-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "ProRx LLC", "state": "PA", "product_description": "Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-08", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot Prorx051425-2, Lot Prorx051425-3 and Lot Prorx051425-4", "product_quantity": "8,310 vials", "distribution_pattern": "TX and UT", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-10-15", "center_classification_date": "2025-10-27", "report_date": "2025-11-05", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0117-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "ProRx LLC", "state": "PA", "product_description": "Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot Prorx051525-1, Prorx051525-2, Prorx051525-3 and Prorx051525-4", "product_quantity": "11,119 vials", "distribution_pattern": "TX and UT", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-10-15", "center_classification_date": "2025-10-27", "report_date": "2025-11-05", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0118-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "ProRx LLC", "state": "PA", "product_description": "Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-06", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot Prorx051525-5", "product_quantity": "2,649 vials", "distribution_pattern": "TX and UT", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-10-15", "center_classification_date": "2025-10-27", "report_date": "2025-11-05", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0119-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "ProRx LLC", "state": "PA", "product_description": "Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-02", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot PRORX052125-4", "product_quantity": "2,805 vials", "distribution_pattern": "TX and UT", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-10-15", "center_classification_date": "2025-10-27", "report_date": "2025-11-05", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Tirzepatide", "matched_compound_slugs": "tirzepatide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0120-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "ProRx LLC", "state": "PA", "product_description": "Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-209-03", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot PRORX08062025-3", "product_quantity": "2,761 vials", "distribution_pattern": "TX and UT", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-10-15", "center_classification_date": "2025-10-27", "report_date": "2025-11-05", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "GHK-Cu", "matched_compound_slugs": "ghk-cu", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0051-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "GenoGenix LLC", "state": "FL", "product_description": "GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lots within expiry.", "product_quantity": "221", "distribution_pattern": "US Nationwide.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-30", "center_classification_date": "2025-10-21", "report_date": "2025-10-15", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0052-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "GenoGenix LLC", "state": "FL", "product_description": "Glutathione Magnesium for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health.", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lots within expiry.", "product_quantity": null, "distribution_pattern": "US Nationwide.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-30", "center_classification_date": "2025-10-21", "report_date": "2025-10-15", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0053-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "GenoGenix LLC", "state": "FL", "product_description": "Glutathione Preserved for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lots within expiry.", "product_quantity": "907", "distribution_pattern": "US Nationwide.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-30", "center_classification_date": "2025-10-21", "report_date": "2025-10-15", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "NAD+", "matched_compound_slugs": "nad-plus", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0065-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "GenoGenix LLC", "state": "FL", "product_description": "NAD+ (Nicotinamide adenine dinucleotide), a) 50 mg/mL, b) 100 mg/mL, 10 mL multi-dose vials, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lots within expiry.", "product_quantity": null, "distribution_pattern": "US Nationwide.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-30", "center_classification_date": "2025-10-21", "report_date": "2025-10-15", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0083-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "GenoGenix LLC", "state": "FL", "product_description": "Semaglutide with B12 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lots within expiry.", "product_quantity": null, "distribution_pattern": "US Nationwide.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-30", "center_classification_date": "2025-10-21", "report_date": "2025-10-15", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "BPC-157", "matched_compound_slugs": "bpc-157", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0085-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "GenoGenix LLC", "state": "FL", "product_description": "BPC-157 for Injection, 15mg/10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Medical Health Institute (MHI), 15mg, 10mL vial lyophilized.", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot#: GG012825-002 within expiry.", "product_quantity": null, "distribution_pattern": "US Nationwide.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-30", "center_classification_date": "2025-10-21", "report_date": "2025-10-15", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "BPC-157; TB-500", "matched_compound_slugs": "bpc-157; tb-500", "includes_class_comparator": false, "search_match_count": 2, "recall_number": "D-0086-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "GenoGenix LLC", "state": "FL", "product_description": "BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health, Extension Health and Medical Health Institute (MHI).", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot#: GG020525-001, GG060525-001, GG062625-004, within expiry.", "product_quantity": null, "distribution_pattern": "US Nationwide.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-30", "center_classification_date": "2025-10-21", "report_date": "2025-10-15", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "TB-500", "matched_compound_slugs": "tb-500", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0087-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "GenoGenix LLC", "state": "FL", "product_description": "Thymosin Beta-4 (TB4) for Injection, 15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot#: GG060525-001 within expiry.", "product_quantity": null, "distribution_pattern": "US Nationwide.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-30", "center_classification_date": "2025-10-21", "report_date": "2025-10-15", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Tesamorelin", "matched_compound_slugs": "tesamorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0088-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "GenoGenix LLC", "state": "FL", "product_description": "Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot#: GG020425-004 within expiry.", "product_quantity": null, "distribution_pattern": "US Nationwide.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-30", "center_classification_date": "2025-10-21", "report_date": "2025-10-15", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Epitalon", "matched_compound_slugs": "epitalon", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0089-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "GenoGenix LLC", "state": "FL", "product_description": "Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extension Health.", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot#: GG053025-002 within expiry", "product_quantity": null, "distribution_pattern": "US Nationwide.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-30", "center_classification_date": "2025-10-21", "report_date": "2025-10-15", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0090-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "GenoGenix LLC", "state": "FL", "product_description": "Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot#: GG062425-002 within expiry.", "product_quantity": null, "distribution_pattern": "US Nationwide.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-30", "center_classification_date": "2025-10-21", "report_date": "2025-10-15", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0091-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "GenoGenix LLC", "state": "FL", "product_description": "Semaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness, 20 mg, 10mL vial lyophilized.", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot#: GG021125-001, GG031125-017, within expiry.", "product_quantity": null, "distribution_pattern": "US Nationwide.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-30", "center_classification_date": "2025-10-21", "report_date": "2025-10-15", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Tirzepatide", "matched_compound_slugs": "tirzepatide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0092-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "GenoGenix LLC", "state": "FL", "product_description": "Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health and Synergy Wellness 60mg, 10mL vial lyophilized.", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lots GG012925-005, GG021125-003, within expiry.", "product_quantity": null, "distribution_pattern": "US Nationwide.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-30", "center_classification_date": "2025-10-21", "report_date": "2025-10-15", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Retatrutide", "matched_compound_slugs": "retatrutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0093-2026", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "GenoGenix LLC", "state": "FL", "product_description": "Retatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot#: GG021125-019, within expiry.", "product_quantity": null, "distribution_pattern": "US Nationwide.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-30", "center_classification_date": "2025-10-21", "report_date": "2025-10-15", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "NAD+", "matched_compound_slugs": "nad-plus", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0094-2026", "classification_fda": "Class I", "classification": "class-i", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "GenoGenix LLC", "state": "FL", "product_description": "NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 mg/mL, 10 mL multi-dose amber vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.", "reason_for_recall": "Microbial Contamination of Sterile Products: elevated endotoxin levels", "code_info": "Lot#: GG121624-023, within expiry", "product_quantity": null, "distribution_pattern": "US Nationwide.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-30", "center_classification_date": "2025-10-21", "report_date": "2025-10-15", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0606-2025", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Boothwyn Pharmacy LLC", "state": "PA", "product_description": "Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy", "reason_for_recall": "Subpotent Drug", "code_info": "03202025@5, 03202025@6, 03202025@7, 03202025@8 BUD 07/18/2025", "product_quantity": "642 vials", "distribution_pattern": "U.S. Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-09", "center_classification_date": "2025-08-29", "report_date": "2025-09-10", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0608-2025", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Boothwyn Pharmacy LLC", "state": "PA", "product_description": "Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy", "reason_for_recall": "Subpotent Drug", "code_info": "03202025@9 BUD 07/18/2025", "product_quantity": "186 vials", "distribution_pattern": "U.S. Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-09", "center_classification_date": "2025-08-29", "report_date": "2025-09-10", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0609-2025", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Boothwyn Pharmacy LLC", "state": "PA", "product_description": "Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy", "reason_for_recall": "Subpotent Drug", "code_info": "03202025@2, 03202025@3 and 03202025@4 BUD 07/18/2025", "product_quantity": "648 vials", "distribution_pattern": "U.S. Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-09", "center_classification_date": "2025-08-29", "report_date": "2025-09-10", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0553-2025", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "AEQUITA PHARMACY", "state": "WA", "product_description": "Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.", "reason_for_recall": "Lack of Processing Controls.", "code_info": "All Lots within expiry", "product_quantity": "290 vials", "distribution_pattern": "MA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-18", "center_classification_date": "2025-08-01", "report_date": "2025-08-13", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Tirzepatide", "matched_compound_slugs": "tirzepatide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0554-2025", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "AEQUITA PHARMACY", "state": "WA", "product_description": "Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.", "reason_for_recall": "Lack of Processing Controls.", "code_info": "All Lots within expiry", "product_quantity": "236 vials", "distribution_pattern": "MA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-18", "center_classification_date": "2025-08-01", "report_date": "2025-08-13", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Tirzepatide", "matched_compound_slugs": "tirzepatide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0555-2025", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "AEQUITA PHARMACY", "state": "WA", "product_description": "Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.", "reason_for_recall": "Lack of Processing Controls.", "code_info": "All Lots within expiry.", "product_quantity": "170 vials", "distribution_pattern": "MA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-18", "center_classification_date": "2025-08-01", "report_date": "2025-08-13", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Tirzepatide", "matched_compound_slugs": "tirzepatide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0556-2025", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "AEQUITA PHARMACY", "state": "WA", "product_description": "Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.", "reason_for_recall": "Lack of Processing Controls.", "code_info": "All Lots within expiry.", "product_quantity": "160 vials", "distribution_pattern": "MA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-18", "center_classification_date": "2025-08-01", "report_date": "2025-08-13", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Tirzepatide", "matched_compound_slugs": "tirzepatide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0557-2025", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "AEQUITA PHARMACY", "state": "WA", "product_description": "Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.", "reason_for_recall": "Lack of Processing Controls.", "code_info": "All Lots within expiry.", "product_quantity": "139 vials", "distribution_pattern": "MA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-18", "center_classification_date": "2025-08-01", "report_date": "2025-08-13", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Tirzepatide", "matched_compound_slugs": "tirzepatide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0558-2025", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "AEQUITA PHARMACY", "state": "WA", "product_description": "Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.", "reason_for_recall": "Lack of Processing Controls.", "code_info": "All Lots within expiry.", "product_quantity": "146 vials", "distribution_pattern": "MA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-18", "center_classification_date": "2025-08-01", "report_date": "2025-08-13", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Tirzepatide", "matched_compound_slugs": "tirzepatide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0559-2025", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "AEQUITA PHARMACY", "state": "WA", "product_description": "Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.", "reason_for_recall": "Lack of Processing Controls.", "code_info": "All Lots within expiry.", "product_quantity": "143 vials", "distribution_pattern": "MA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-18", "center_classification_date": "2025-08-01", "report_date": "2025-08-13", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Tirzepatide", "matched_compound_slugs": "tirzepatide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0560-2025", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "AEQUITA PHARMACY", "state": "WA", "product_description": "Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 3 x 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.", "reason_for_recall": "Lack of Processing Controls.", "code_info": "All Lots within expiry.", "product_quantity": "155 vials", "distribution_pattern": "MA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-18", "center_classification_date": "2025-08-01", "report_date": "2025-08-13", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0561-2025", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "AEQUITA PHARMACY", "state": "WA", "product_description": "Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.", "reason_for_recall": "Lack of Processing Controls.", "code_info": "All Lots within expiry.", "product_quantity": "221 vials", "distribution_pattern": "MA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-18", "center_classification_date": "2025-08-01", "report_date": "2025-08-13", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0562-2025", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "AEQUITA PHARMACY", "state": "WA", "product_description": "Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.", "reason_for_recall": "Lack of Processing Controls.", "code_info": "All Lots within expiry.", "product_quantity": "194 vials", "distribution_pattern": "MA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-18", "center_classification_date": "2025-08-01", "report_date": "2025-08-13", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0563-2025", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "AEQUITA PHARMACY", "state": "WA", "product_description": "Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.", "reason_for_recall": "Lack of Processing Controls.", "code_info": "All Lots within expiry.", "product_quantity": "190 vials", "distribution_pattern": "MA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-18", "center_classification_date": "2025-08-01", "report_date": "2025-08-13", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0564-2025", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "AEQUITA PHARMACY", "state": "WA", "product_description": "Semaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.", "reason_for_recall": "Lack of Processing Controls.", "code_info": "All Lots within expiry.", "product_quantity": "176 vials", "distribution_pattern": "MA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-18", "center_classification_date": "2025-08-01", "report_date": "2025-08-13", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0565-2025", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "AEQUITA PHARMACY", "state": "WA", "product_description": "Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.", "reason_for_recall": "Lack of Processing Controls.", "code_info": "All Lots within expiry.", "product_quantity": "158 vials", "distribution_pattern": "MA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-07-18", "center_classification_date": "2025-08-01", "report_date": "2025-08-13", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "CJC-1295", "matched_compound_slugs": "cjc-1295", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0475-2025", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)", "state": "CO", "product_description": "CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot#: H261968, Exp 12/23/2025; H261358, Exp 5/13/2025", "product_quantity": "60 syringes", "distribution_pattern": "USA Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-05-21", "center_classification_date": "2025-06-20", "report_date": "2025-07-02", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "NAD+", "matched_compound_slugs": "nad-plus", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0478-2025", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)", "state": "CO", "product_description": "Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot #: O-O8A01-25, Exp 3/7/2025", "product_quantity": "16 syringes", "distribution_pattern": "USA Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-05-21", "center_classification_date": "2025-06-20", "report_date": "2025-07-02", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0479-2025", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)", "state": "CO", "product_description": "Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot #: H270221, Exp 12/26/2025", "product_quantity": "32 syringes", "distribution_pattern": "USA Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-05-21", "center_classification_date": "2025-06-20", "report_date": "2025-07-02", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0480-2025", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)", "state": "CO", "product_description": "Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot #: C03035J, Exp 7/3/2025, H202959, exp 7/6/2025; AB20N110720 , exp 7/7/2025 ; AB60N1121, exp 7/7/2025; PRX022225-1 , exp 8/24/2025 ; U122024 , exp 10/26/2025", "product_quantity": "164 syringes", "distribution_pattern": "USA Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-05-21", "center_classification_date": "2025-06-20", "report_date": "2025-07-02", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0481-2025", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)", "state": "CO", "product_description": "Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot: C03075J, Ex p 7/7/2025", "product_quantity": "28 syringes", "distribution_pattern": "USA Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-05-21", "center_classification_date": "2025-06-20", "report_date": "2025-07-02", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Tirzepatide", "matched_compound_slugs": "tirzepatide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0482-2025", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)", "state": "CO", "product_description": "Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot, expiry: H272962, exp 12/5/2025; S5045185, exp 5/20/2025; H272962, exp 12/5/2025; H270625, exp 9/30/2025", "product_quantity": "24 syringes", "distribution_pattern": "USA Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-05-21", "center_classification_date": "2025-06-20", "report_date": "2025-07-02", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Tirzepatide", "matched_compound_slugs": "tirzepatide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0483-2025", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)", "state": "CO", "product_description": "Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot #BH11235 exp 5/5/2025 ; BH11235 , exp 5/5/2025 ; BH11235 , exp 5/5/2025 ; BH11235 , exp 5/5/2025 ; BH11235 , exp 5/5/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; BH272962 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; BH272962 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; BH00048 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRO30625-2 , exp 9/2/2025 ; PRO30625-2 , exp 9/2/2025 ; PRO30625-2 , exp 9/2/2025 ; PRX012825-2 , exp 9/27/2025 ; PRX012825-2 , exp 9/27/2025 ; PRX012825-2 , exp 9/27/2025 ; PRX012825-2 , exp 9/27/2025 ; PRX012825-2 , exp 9/27/2025 ; PRX012825-2 , exp 9/27/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ;", "product_quantity": "826 syringes", "distribution_pattern": "USA Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-05-21", "center_classification_date": "2025-06-20", "report_date": "2025-07-02", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Tirzepatide", "matched_compound_slugs": "tirzepatide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0484-2025", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)", "state": "CO", "product_description": "Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot: H388348", "product_quantity": "4 syringes", "distribution_pattern": "USA Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-05-21", "center_classification_date": "2025-06-20", "report_date": "2025-07-02", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Tirzepatide", "matched_compound_slugs": "tirzepatide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0485-2025", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)", "state": "CO", "product_description": "Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot: C03065F", "product_quantity": "216 syringes", "distribution_pattern": "USA Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-05-21", "center_classification_date": "2025-06-20", "report_date": "2025-07-02", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Tirzepatide", "matched_compound_slugs": "tirzepatide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0486-2025", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)", "state": "CO", "product_description": "Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot: C03125A", "product_quantity": "242 syringes", "distribution_pattern": "USA Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-05-21", "center_classification_date": "2025-06-20", "report_date": "2025-07-02", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "NAD+", "matched_compound_slugs": "nad-plus", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0487-2025", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)", "state": "CO", "product_description": "Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot: GA37484", "product_quantity": "16 syringes", "distribution_pattern": "USA Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-05-21", "center_classification_date": "2025-06-20", "report_date": "2025-07-02", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0393-2025", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Cardinal Health Inc.", "state": "OH", "product_description": "Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose Only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, DK-2880, Bagsvaerd, Denmark, NDC 0169-4524-14.", "reason_for_recall": "Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.", "code_info": "Lot PZFDE06, Exp 08/31/2025", "product_quantity": "48 Cartons", "distribution_pattern": "NC, SC, VA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2025-04-09", "center_classification_date": "2025-04-28", "report_date": "2025-05-07", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0650-2024", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "ProRx LLC", "state": "PA", "product_description": "Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-01", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot #: ProRx031924, BUD 09/18/2024 ProRx032624, BUD 09/25/2024 ProRx041324, BUD 10/12/2024", "product_quantity": "2,490 vials", "distribution_pattern": "Nationwide in the USA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2024-08-22", "center_classification_date": "2024-09-05", "report_date": "2024-09-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Tirzepatide", "matched_compound_slugs": "tirzepatide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0651-2024", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "ProRx LLC", "state": "PA", "product_description": "Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, NDC 84139-210-01", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot # ProRx040924-1, BUD 10/08/2024", "product_quantity": "37 vials", "distribution_pattern": "Nationwide in the USA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2024-08-22", "center_classification_date": "2024-09-05", "report_date": "2024-09-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0652-2024", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "ProRx LLC", "state": "PA", "product_description": "SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-01", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot #: ProRx052424, BUD 11/23/2024 ProRx060724, BUD 12/06/2024 ProRx061124, BUD 12/10/2024 ProRx061924, BUD 12/18/2024", "product_quantity": "8,396 vials", "distribution_pattern": "Nationwide in the USA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2024-08-22", "center_classification_date": "2024-09-05", "report_date": "2024-09-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0653-2024", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "ProRx LLC", "state": "PA", "product_description": "SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "ProRx061424, BUD 12/13/2024", "product_quantity": "1,960 vials", "distribution_pattern": "Nationwide in the USA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2024-08-22", "center_classification_date": "2024-09-05", "report_date": "2024-09-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0654-2024", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "ProRx LLC", "state": "PA", "product_description": "Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, Compounded Rx Product, ProRX 267-565-7008, NDC 84139-225-02", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot # ProRx031924-1, BUD 09/18/2024", "product_quantity": "500 vials", "distribution_pattern": "Nationwide in the USA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2024-08-22", "center_classification_date": "2024-09-05", "report_date": "2024-09-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Tirzepatide", "matched_compound_slugs": "tirzepatide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0655-2024", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "ProRx LLC", "state": "PA", "product_description": "TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot # ProRx051424, BUD 11/13/2024", "product_quantity": "1,489 vials", "distribution_pattern": "Nationwide in the USA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2024-08-22", "center_classification_date": "2024-09-05", "report_date": "2024-09-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Tirzepatide", "matched_compound_slugs": "tirzepatide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0656-2024", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "ProRx LLC", "state": "PA", "product_description": "TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot# ProRx052224, BUD 11/21/2024 ProRx061024, BUD 12/09/2024", "product_quantity": "1,732 vials", "distribution_pattern": "Nationwide in the USA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2024-08-22", "center_classification_date": "2024-09-05", "report_date": "2024-09-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Tirzepatide", "matched_compound_slugs": "tirzepatide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0511-2024", "classification_fda": "Class I", "classification": "class-i", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Revive Rx LLC dba Revive Rx Pharmacy", "state": "TX", "product_description": "Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pharmacy, 3831 Golf Dr A, Houston, TX 77018, internally assigned NDC 99000-9278-64", "reason_for_recall": "Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate", "code_info": "Lot #: 748127, Exp 9/24/2024", "product_quantity": "751 vials", "distribution_pattern": "USA Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2024-04-20", "center_classification_date": "2024-05-29", "report_date": "2024-06-05", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1105-2023", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "TMC Acquisitions LLC dba Tailor Made Compounding", "state": "KY", "product_description": "Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding.", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot#: 07262326A1, BUD: 10/24/2023", "product_quantity": "9 vials", "distribution_pattern": "Nationwide within the USA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2023-08-15", "center_classification_date": "2023-08-24", "report_date": "2023-08-30", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "NAD+", "matched_compound_slugs": "nad-plus", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1106-2023", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "TMC Acquisitions LLC dba Tailor Made Compounding", "state": "KY", "product_description": "NAD+ 200mg/ml, 10ml vials, Tailor Made Compounding.", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot#: 07192307A2, BUD: 11/18/2023", "product_quantity": "99 vials", "distribution_pattern": "Nationwide within the USA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2023-08-15", "center_classification_date": "2023-08-24", "report_date": "2023-08-30", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Tirzepatide", "matched_compound_slugs": "tirzepatide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0771-2023", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Revive Rx LLC dba Revive Rx Pharmacy", "state": "TX", "product_description": "Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug Product By: Revive Rx, 3831 Golf Dr A, Houston, TX 77018, NDC: 99000-9278-64.", "reason_for_recall": "Sub-potent Drug", "code_info": "Lot: 1643397 BUD: 10/16/2023", "product_quantity": "45 Vials", "distribution_pattern": "Nationwide in the US", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2023-05-11", "center_classification_date": "2023-05-25", "report_date": "2023-05-31", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0538-2023", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Pharmacy Plus, Inc. dba Vital Care Compounder", "state": "MS", "product_description": "C-Semaglutide 5mg/mL injection, 0.5mL vials, Rx only, Vital Care Compounder 115 South 40th Ave, Suite A Hattiesburg, MS 39402", "reason_for_recall": "Lack of assurance of sterility.", "code_info": "Lot #: 73810, Exp. Date 5/1/2023", "product_quantity": "45 vials", "distribution_pattern": "MS only", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2023-04-13", "center_classification_date": "2023-04-19", "report_date": "2023-04-26", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0210-2023", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Pharmacy Innovations", "state": "PA", "product_description": "GLUTATHIONE L REDUCED 100MG/ML (2ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 200MG/ML (1ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 220MG/ML (30ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (1ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (2ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED-PF- 200MG/ML (2ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.", "reason_for_recall": "Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.", "code_info": "t20221129@68 t20221025@32 t20221025@33 t20221114@27 t20221021@40 t20221116@36", "product_quantity": "N/A", "distribution_pattern": "Nationwide in the USA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-12-22", "center_classification_date": "2023-01-26", "report_date": "2023-02-01", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0236-2023", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Pharmacy Innovations", "state": "PA", "product_description": "SEMAGLUTIDE 0.5MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 1MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 2MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 4MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 5.4MG/ML (0.5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.", "reason_for_recall": "Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.", "code_info": "t20221026@52 t20221102@11 t20221004@44 t20221116@36 t20221011@36", "product_quantity": "N/A", "distribution_pattern": "Nationwide in the USA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-12-22", "center_classification_date": "2023-01-26", "report_date": "2023-02-01", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0053-2023", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Pharmacy Plus, Inc. dba Vital Care Compounder", "state": "MS", "product_description": "SEMAGLUTIDE INJECTION 5MG/ML (0.25MG/0.05ML) SOLN, various amounts in unit dose vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402", "reason_for_recall": "Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.", "code_info": "Lots: 65680, BUD: 10/11/2022; 66043, BUD: 10/15/2022; 66372, BUD: 10/23/2022; 66597, BUD: 10/29/2022", "product_quantity": "800.5 mL in unit dose vials", "distribution_pattern": "AL, LA, MS, and TN", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-10-07", "center_classification_date": "2022-11-02", "report_date": "2022-11-09", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1518-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Completed", "status": "completed", "recalling_firm": "Carolina Infusion", "state": "SC", "product_description": "Sermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lots: 08012022@14 BUD: 08/31/2022; 08192022@7 BUD: 09/23/2022", "product_quantity": "8 syringes", "distribution_pattern": "Nationwide in the USA.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-08-26", "center_classification_date": "2022-09-15", "report_date": "2022-09-21", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1519-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Completed", "status": "completed", "recalling_firm": "Carolina Infusion", "state": "SC", "product_description": "Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lots: 08122022@8 BUD: 09/11/2022; 08162022@3 BUD: 09/15/2022", "product_quantity": "24 syringes", "distribution_pattern": "Nationwide in the USA.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-08-26", "center_classification_date": "2022-09-15", "report_date": "2022-09-21", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1520-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Completed", "status": "completed", "recalling_firm": "Carolina Infusion", "state": "SC", "product_description": "Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot: 08152022@14 BUD: 09/14/2022", "product_quantity": "4 syringes", "distribution_pattern": "Nationwide in the USA.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-08-26", "center_classification_date": "2022-09-15", "report_date": "2022-09-21", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1521-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Completed", "status": "completed", "recalling_firm": "Carolina Infusion", "state": "SC", "product_description": "Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot: 08172022@1 BUD: 09/16/2022", "product_quantity": "4 syringes", "distribution_pattern": "Nationwide in the USA.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-08-26", "center_classification_date": "2022-09-15", "report_date": "2022-09-21", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1205-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "TMC Acquisition LLC dba Tailor Made Compounding", "state": "KY", "product_description": "Glutathione 200mg/mL Preservative Free, Injectable, 30mL-vial, Refrigerate, Tailor Made Compounding", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Batch #: 12062113A2, Exp 3/6/2022; 01052209B, Exp 4/5/2022; 01312223A1, Exp 5/1/2022.", "product_quantity": "40 vials", "distribution_pattern": "Nationwide USA and Puerto Rico", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-03-07", "center_classification_date": "2022-07-14", "report_date": "2022-07-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Melanotan II", "matched_compound_slugs": "melanotan-2", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1212-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "TMC Acquisition LLC dba Tailor Made Compounding", "state": "KY", "product_description": "Melanotan I 200mcg/mL (2mg/ml), a) 1.5mL-vial, b) 5 mL-vial, Refrigerate, Tailor Made Compounding", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Batch #: a) 01072212A1, Exp 4/7/2022; 03032220A1, Exp 6/1/2022; b) 12162120A2, Exp 3/16/2022; 01142205A1, Exp 4/14/2022; 02012226A1, Exp 5/2/2022; 03032220A1, Exp 6/1/2022.", "product_quantity": "182 vials", "distribution_pattern": "Nationwide USA and Puerto Rico", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-03-07", "center_classification_date": "2022-07-14", "report_date": "2022-07-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "NAD+", "matched_compound_slugs": "nad-plus", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1219-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "TMC Acquisition LLC dba Tailor Made Compounding", "state": "KY", "product_description": "NAD+ 200mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Batch#: 10072110A2, 10142102A2, Exp 3/22/2022; 01112205A1, 11112123A1, Exp 4/30/2022; 11222114A1, 11172107A1, 11182120A2, Exp 5/7/2022; 01102207A1, 01122211A1, Exp 5/11/2022; 12162119A1, 12162121A1, Exp 5/24/20220; 02022223A2, Exp 6/30/2022; 03012204A1, Exp 8/23/2022; 03082249B, Exp 9/4/2022; 03092226B, 03092236B, Exp 9/5/2022.", "product_quantity": "1,856 vials", "distribution_pattern": "Nationwide USA and Puerto Rico", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-03-07", "center_classification_date": "2022-07-14", "report_date": "2022-07-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "PT-141", "matched_compound_slugs": "pt-141", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1223-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "TMC Acquisition LLC dba Tailor Made Compounding", "state": "KY", "product_description": "PT-141 10mg/mL a) 1mL-vial, b) 2 mL-vial, Refrigerate, Tailor Made Compounding", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Batch#: a) 01042226A2, Exp 4/4/2022; 01242228A2, Exp 4/24/2022; 02212208A1, Exp 5/22/2022; b) 01192230A2, Exp 4/19/2022; 02212217A1, Exp 5/22/2022.", "product_quantity": "392 vials", "distribution_pattern": "Nationwide USA and Puerto Rico", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-03-07", "center_classification_date": "2022-07-14", "report_date": "2022-07-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1224-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "TMC Acquisition LLC dba Tailor Made Compounding", "state": "KY", "product_description": "Semaglutide/Cyanocobalamin 2mg/0.4mg/ml, 1mL-vial, Refrigerate, Tailor Made Compounding", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Batch#: 12032123A2, Exp 3/3/2022; 12102101A2, Exp 3/10/2022; 12202105A2, Exp 3/20/2022; 12292106A2, Exp 3/29/2022; 01062218B, Exp 4/6/2022; 01192228A2, Exp 4/19/2022; 01312214A2, Exp 5/1/2022; 02012211A1, Exp 5/2/2022; 02182201A1, 02182203A1, Exp 5/19/2022; 02242205A1, 02242206A1, Exp 5/25/2022; 03072209A1, Exp 6/5/2022; 03092203A1, 03092206A1, Exp 6/7/2022.", "product_quantity": "5,842 vials", "distribution_pattern": "Nationwide USA and Puerto Rico", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-03-07", "center_classification_date": "2022-07-14", "report_date": "2022-07-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1225-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "TMC Acquisition LLC dba Tailor Made Compounding", "state": "KY", "product_description": "Semaglutide/Cyanocobalamin 5mg/0.2mg/ml, 2ml-vial, Refrigerate, Tailor Made Compounding", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Batch#: 12092115A2, Exp 3/9/2022; 12162116A2, Exp 3/16/2022; 12212106A2, Exp 3/21/2022; 01062219B, Exp 4/6/2022; 01072205A1, 01072208A1, Exp 4/7/2022; 01102203A1, Exp 4/10/2022; 01132207A1, Exp 4/13/2022; 01192216A1, Exp 4/19/2022; 01202204A2, Exp 4/20/2022; 01272223A2, Exp 4/27/2022; 01312219A2, Exp 5/1/2022; 02032204A2, Exp 5/4/2022; 02072203A1, Exp 5/8/2022; 02182216A1, 02182224A1, Exp 5/19/2022; 02232202A1, 02232210A1, Exp 5/24/2022; 02242202A1, 02242203A1, 02242235A1, 02242238A1, Exp 5/25/2022; 03072217A1, 03072223A1, Exp 6/5/2022; 03082223A1, 03082229A1, Exp 6/6/2022; 03092207A1, 03092219A1, Exp 6/7/2022.", "product_quantity": "9,993 vials", "distribution_pattern": "Nationwide USA and Puerto Rico", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-03-07", "center_classification_date": "2022-07-14", "report_date": "2022-07-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1226-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "TMC Acquisition LLC dba Tailor Made Compounding", "state": "KY", "product_description": "Sermorelin 2000mcg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Batch#: 10122103A2, Exp 3/22/2022; 11092108A2, Exp 4/30/2022; 11192115A2, Exp 5/7/2022; 12022107A2, Exp 5/22/2022; 12132107A2, Exp 5/24/2022; 01182201A2, Exp 6/30/2022; 02142212A1, Exp 8/13/2022; 03022217A1, Exp 8/29/2022.", "product_quantity": "1,208 vials", "distribution_pattern": "Nationwide USA and Puerto Rico", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-03-07", "center_classification_date": "2022-07-14", "report_date": "2022-07-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1227-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "TMC Acquisition LLC dba Tailor Made Compounding", "state": "KY", "product_description": "Sermorelin/Glycine 2000mcg/5mg/mL, 4mL-vial, Refrigerate, Tailor Made Compounding", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Batch#: 11102107A2, Exp 4/9/202211232104A1, Exp 5/7/2022; 02212229A1, 11292103A2, Exp 5/22/2022; 12132105A2, Exp 5/24/2022; 02282207A1, Exp 5/29/2022; 03082209A1, Exp 6/6/2022; 03112231B, Exp 6/9/2022; 01042212A1, Exp 6/27/2022.", "product_quantity": "1,562 vials", "distribution_pattern": "Nationwide USA and Puerto Rico", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-03-07", "center_classification_date": "2022-07-14", "report_date": "2022-07-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1228-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "TMC Acquisition LLC dba Tailor Made Compounding", "state": "KY", "product_description": "Sermorelin/Glycine 2000mcg/5mg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Batch #: 10122102A2, Exp 3/22/2022; 10252101A2, Exp 3/24/2022; 11092106A2, Exp 4/8/2022; 11232102A1, Exp 5/7/2022; 11162106A1, Exp 5/15/2022; 12032114A1, 02212224A1, Exp 5/22/2022; 12142111A1, 12202109A2, Exp 5/24/2022; 03032244A1, Exp 6/1/2022; 03082209A1, Exp 6/6/2022; 12292116A2, Exp 6/27/2022; 01182204A1, 01262232A1, 01262233A1, Exp 6/30/2022.", "product_quantity": "2,870 vials", "distribution_pattern": "Nationwide USA and Puerto Rico", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-03-07", "center_classification_date": "2022-07-14", "report_date": "2022-07-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1243-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "TMC Acquisition LLC dba Tailor Made Compounding", "state": "KY", "product_description": "Glutathione 200mg/ml, a) 10ml-vial, b) 30ml-vial, Refrigerate, Tailor Made Compounding", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Batch#: a) 01122204A1, Exp 4/12/2022; 02192214A1, Exp 5/20/2022; b) 12142122A2, Exp. 3/14/2022; 12282118A2, Exp 3/28/2022; 01112203A1, Exp 4/11/2022; 01122208A1, Exp 4/12/2022; 01202211A2, Exp 4/20/2022; 02032205A1, Exp 5/4/2022; 02192212A1, Exp 5/20/2022; 03042201A1, Exp 6/2/2022.", "product_quantity": "485 Vials", "distribution_pattern": "Nationwide USA and Puerto Rico", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-03-07", "center_classification_date": "2022-07-14", "report_date": "2022-07-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0902-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Completed", "status": "completed", "recalling_firm": "Olympia Compounding Pharmacy dba Olympia Pharmacy", "state": "FL", "product_description": "Sermorelin Acetate Lyophilized powder for reconstitution 9 mg Per Multi-Dose Vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0059-00", "reason_for_recall": "Lack of assurance of sterility.", "code_info": "Lots: L24115 BUD: 12/15/2022; A24203 BUD: 01/03/2023; A24106 BUD: 01/06/2023", "product_quantity": "4459 vials", "distribution_pattern": "Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-05-09", "center_classification_date": "2022-05-25", "report_date": "2022-06-01", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0913-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Completed", "status": "completed", "recalling_firm": "Olympia Compounding Pharmacy dba Olympia Pharmacy", "state": "FL", "product_description": "Tri-Immune Boost Glutathione 200 mg/mL Ascorbic Acid 200 mg/mL Zinc Sulfate 2.5 mg/mL Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0104-30", "reason_for_recall": "Lack of assurance of sterility.", "code_info": "Lots: B24D01-22, B24C01-22 BUD: 6/1/2022", "product_quantity": "2260 vials", "distribution_pattern": "Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-05-09", "center_classification_date": "2022-05-25", "report_date": "2022-06-01", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "NAD+", "matched_compound_slugs": "nad-plus", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0939-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Completed", "status": "completed", "recalling_firm": "Olympia Compounding Pharmacy dba Olympia Pharmacy", "state": "FL", "product_description": "NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, Multi-Dose 500 mg per vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0083-00.", "reason_for_recall": "Lack of assurance of sterility.", "code_info": "Lots: A2401422 BUD: 1/14/2023, K41001 BUD: 11/1/2022, K41130 BUD: 11/30/2022, L24113 BUD: 12/13/2022, L41102 BUD: 12/2/2022", "product_quantity": "8982 vials", "distribution_pattern": "Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-05-09", "center_classification_date": "2022-05-25", "report_date": "2022-06-01", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "NAD+", "matched_compound_slugs": "nad-plus", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0795-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Olympia Compounding Pharmacy dba Olympia Pharmacy", "state": "FL", "product_description": "NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution, Multi-Dose 500 mg Per Vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0083-00", "reason_for_recall": "CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated", "code_info": "Lots: E24026 BUD: 5/26/2022, E42112 BUD: 5/12/2022, E48024 BUD: 2/2/2022, F24014 BUD: 6/14/2022, G48028 BUD: 7/28/2022, H24016 BUD: 8/16/2022, H42010 BUD 8/10/2022, H48030 BUD: 8/11/2022, I47003 BUD: 8/11/2022", "product_quantity": "16,329 vials", "distribution_pattern": "Distributed Nationwide in the USA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-04-04", "center_classification_date": "2022-04-27", "report_date": "2022-05-04", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0797-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Olympia Compounding Pharmacy dba Olympia Pharmacy", "state": "FL", "product_description": "Sermorelin Acetate, Lyophilized powder for reconstitution, Multi-Dose vials, Packaged as a) 3 mg per vial, NDC 73198-0060-00; b) 9 mg NDC 73198-0059-00, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835.", "reason_for_recall": "CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated", "code_info": "Lots: a) D41019 BUD: 4/19/2022; b) D41112 BUD: 4/12/2022, D47028 BUD: 4/28/2022, F24009 BUD 3/4/2022, F41001 BUD: 6/1/2022, G48006 BUD: 7/14/2022, G48008 BUD: 7/8/2022, G48012 BUD: 7/12/2022, G48014 BUD: 7/14/2022, G48019 BUD: 7/9/2022, I24009 BUD: 9/9/2022, I41107 BUD: 9/7/2022", "product_quantity": "18060 vials", "distribution_pattern": "Distributed Nationwide in the USA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-04-04", "center_classification_date": "2022-04-27", "report_date": "2022-05-04", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "NAD+", "matched_compound_slugs": "nad-plus", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0828-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Olympia Compounding Pharmacy dba Olympia Pharmacy", "state": "FL", "product_description": "NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution, Multi-Dose 500 mg Per Vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0083-00", "reason_for_recall": "Failed Reconstitution time", "code_info": "Lot: F41116 BUD: 6/16/2022,", "product_quantity": null, "distribution_pattern": "Distributed Nationwide in the USA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-04-04", "center_classification_date": "2022-04-27", "report_date": "2022-05-04", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "BPC-157", "matched_compound_slugs": "bpc-157", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0776-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding", "state": "TX", "product_description": "BPC-157 2 mg/mL (5 mL) Injection, 5 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081", "reason_for_recall": "Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.", "code_info": "Lot #: 32242 BUD: 4/19/2022; 33911 BUD: 6/8/2022", "product_quantity": "778 vials", "distribution_pattern": "Nationwide within United States", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-04-05", "center_classification_date": "2022-04-21", "report_date": "2022-04-27", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Ipamorelin; Sermorelin", "matched_compound_slugs": "ipamorelin; sermorelin", "includes_class_comparator": false, "search_match_count": 2, "recall_number": "D-0777-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding", "state": "TX", "product_description": "Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081", "reason_for_recall": "Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.", "code_info": "Lot #: 32961 BUD: 5/12/2022", "product_quantity": "189 vials", "distribution_pattern": "Nationwide within United States", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-04-05", "center_classification_date": "2022-04-21", "report_date": "2022-04-27", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "LL-37", "matched_compound_slugs": "ll-37", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0778-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding", "state": "TX", "product_description": "LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA", "reason_for_recall": "Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.", "code_info": "Lot #: 33444 BUD: 4/26/2022", "product_quantity": "25 vials", "distribution_pattern": "Nationwide within United States", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-04-05", "center_classification_date": "2022-04-21", "report_date": "2022-04-27", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Melanotan II", "matched_compound_slugs": "melanotan-2", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0779-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding", "state": "TX", "product_description": "Melanotan II 1 mg/mL (10 mL) Injection, 10mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA", "reason_for_recall": "Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.", "code_info": "Lot #: 32610 BUD: 4/4/2022; 35126 BUD: 6/7/2022", "product_quantity": "35 vials", "distribution_pattern": "Nationwide within United States", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-04-05", "center_classification_date": "2022-04-21", "report_date": "2022-04-27", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "PT-141", "matched_compound_slugs": "pt-141", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0780-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding", "state": "TX", "product_description": "PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081", "reason_for_recall": "Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.", "code_info": "Lot #: 32616 BUD: 4/4/2022; 34527 BUD: 5/24/2022", "product_quantity": "43 vials", "distribution_pattern": "Nationwide within United States", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-04-05", "center_classification_date": "2022-04-21", "report_date": "2022-04-27", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0781-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding", "state": "TX", "product_description": "Sermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081", "reason_for_recall": "Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.", "code_info": "Lot #: 32963 BUD: 4/12/2022; 34824 BUD: 5/30/2022; 35130 BUD: 6/7/2022", "product_quantity": "76 vials", "distribution_pattern": "Nationwide within United States", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-04-05", "center_classification_date": "2022-04-21", "report_date": "2022-04-27", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0718-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Olympia Compounding Pharmacy dba Olympia Pharmacy", "state": "FL", "product_description": "Sermorelin Acetate Lyophilized powder for reconstitution, Multi-Dose 9 mg per vial, Each ML contains: 5% Mannitol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0059-00", "reason_for_recall": "Sub Potent", "code_info": "Lots: D44026 Exp. 4/26/22; F42104 Exp. 6/4/22", "product_quantity": "2283 vials", "distribution_pattern": "Nationwide in the USA including Puerto Rico.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-03-08", "center_classification_date": "2022-03-29", "report_date": "2022-03-30", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "NAD+", "matched_compound_slugs": "nad-plus", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0719-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Olympia Compounding Pharmacy dba Olympia Pharmacy", "state": "FL", "product_description": "NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, Multi-Dose 500 mg per vial, Each ML contains: 0.288% Sodium Phosphate Monobasic USP, 0.42% Sodium Phosphate Dibasic USP, 5% Mannitol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835 NDC: 73198-0083-00", "reason_for_recall": "Product found to be Sub Potent or Exceeded reconstitution time", "code_info": "Lot: D24005 Exp. 4/5/22; C41008 Exp. 3/8/22", "product_quantity": "2634 vials", "distribution_pattern": "Nationwide in the USA including Puerto Rico.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2022-03-08", "center_classification_date": "2022-03-29", "report_date": "2022-03-30", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "CJC-1295; Ipamorelin", "matched_compound_slugs": "cjc-1295; ipamorelin", "includes_class_comparator": false, "search_match_count": 2, "recall_number": "D-0109-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Vita Pharmacy, LLC dba Talon Compounding Pharmacy", "state": "TX", "product_description": "CJC-1295 4MG/IPAMORELIN 4MG VIAL 4MG/4MG INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247", "reason_for_recall": "Lack of assurance of sterility", "code_info": "Lot: 05242021:73 BUD: 08/22/2021; 08032021:26 BUD: 11/01/2021; 06022021:49 BUD: 08/31/2021; 08122021:97 BUD: 11/10/2021;", "product_quantity": "15 vials", "distribution_pattern": "United States including Washington, D.C. and Puerto Rico", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2021-10-12", "center_classification_date": "2021-11-08", "report_date": "2021-11-17", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Ipamorelin; Sermorelin", "matched_compound_slugs": "ipamorelin; sermorelin", "includes_class_comparator": false, "search_match_count": 2, "recall_number": "D-0143-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Vita Pharmacy, LLC dba Talon Compounding Pharmacy", "state": "TX", "product_description": "SERMORELIN ACETATE 15MG/IPAMORELIN 15MG - LYOPHILIZED 15MG/15MG VIAL, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247", "reason_for_recall": "Lack of assurance of sterility", "code_info": "Lot: 07062021:98 BUD: 11/30/2021", "product_quantity": "6 vials", "distribution_pattern": "United States including Washington, D.C. and Puerto Rico", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2021-10-12", "center_classification_date": "2021-11-08", "report_date": "2021-11-17", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Ipamorelin; Sermorelin", "matched_compound_slugs": "ipamorelin; sermorelin", "includes_class_comparator": false, "search_match_count": 2, "recall_number": "D-0144-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Vita Pharmacy, LLC dba Talon Compounding Pharmacy", "state": "TX", "product_description": "SERMORELIN ACETATE 6MG/IPAMORELIN 6MG - LYOPHILIZED 6MG/6MG VIAL, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247", "reason_for_recall": "Lack of assurance of sterility", "code_info": "Lot: 06022021:03 BUD: 11/29/2021; 08102021:27 BUD: 11/30/2021; 05212021:84 BUD: 11/17/2021", "product_quantity": "11 vials", "distribution_pattern": "United States including Washington, D.C. and Puerto Rico", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2021-10-12", "center_classification_date": "2021-11-08", "report_date": "2021-11-17", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Ipamorelin; Sermorelin", "matched_compound_slugs": "ipamorelin; sermorelin", "includes_class_comparator": false, "search_match_count": 2, "recall_number": "D-0145-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Vita Pharmacy, LLC dba Talon Compounding Pharmacy", "state": "TX", "product_description": "SERMORELIN ACETATE 9MG/IPAMORELIN 9MG - LYOPHILIZED 9MG/9MG VIAL, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247", "reason_for_recall": "Lack of assurance of sterility", "code_info": "Lot: 08102021:22 BUD: 11/30/2021", "product_quantity": "3 vials", "distribution_pattern": "United States including Washington, D.C. and Puerto Rico", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2021-10-12", "center_classification_date": "2021-11-08", "report_date": "2021-11-17", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0033-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy", "state": "AZ", "product_description": "ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx", "reason_for_recall": "Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns", "code_info": "all lots within expiry", "product_quantity": "N/A", "distribution_pattern": "494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2021-08-13", "center_classification_date": "2021-10-26", "report_date": "2021-11-03", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0038-2022", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy", "state": "AZ", "product_description": "GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx", "reason_for_recall": "Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns", "code_info": "all lots within expiry", "product_quantity": "N/A", "distribution_pattern": "494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2021-08-13", "center_classification_date": "2021-10-26", "report_date": "2021-11-03", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Ipamorelin", "matched_compound_slugs": "ipamorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0692-2021", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Completed", "status": "completed", "recalling_firm": "Innoveix Pharmaceuticals Inc", "state": "TX", "product_description": "Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot #: SIP215 Exp. 01/14/2022, SIP220 Exp. 01/23/2022, SIP210 Exp. 12/15/2021", "product_quantity": "728 vials", "distribution_pattern": "Nationwide within the United States", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2021-07-09", "center_classification_date": "2021-07-20", "report_date": "2021-07-28", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "AOD-9604", "matched_compound_slugs": "aod-9604", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0693-2021", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Completed", "status": "completed", "recalling_firm": "Innoveix Pharmaceuticals Inc", "state": "TX", "product_description": "Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot #: AOD205 Exp. 11/09/2021; AOD210 Exp. 11/18/2021; AOD215 Exp. 12/15/2021; AOD220 Exp. 01/20/2022.", "product_quantity": "1,316 vials", "distribution_pattern": "Nationwide within the United States", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2021-07-09", "center_classification_date": "2021-07-20", "report_date": "2021-07-28", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0536-2021", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Cardinal Health Inc.", "state": "OH", "product_description": "Rybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg semaglutide 30 tablets 3 blister packs. Each pack contains 10 tablets. Rx only NDC 0169-4307-13 Manufactured by: Novo Nordisk A/S DK-2880 Bagsvaerd, Denmark", "reason_for_recall": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.", "code_info": "K082347", "product_quantity": "1189 cartons", "distribution_pattern": "FL, GA, SC", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2021-03-15", "center_classification_date": "2021-05-24", "report_date": "2021-06-02", "fda_matched_an_approved_listing": true }, { "matched_search_terms": "Semaglutide", "matched_compound_slugs": "semaglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0617-2021", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Novo Nordisk Inc", "state": "NJ", "product_description": "OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen, Sample. Not for Resale, Rx only, Novo Nordisk Inc, Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-4132-90 (Pen), NDC 0169-4132-97 (Kit)", "reason_for_recall": "Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.", "code_info": "KP50867, exp 10/31/2022, KP53021, exp 04/30/2023, KP52338, exp 02/28/2023, JP54354, exp 08/31/2022, KP50676, exp 10/31/2022, KP51434, exp 11/30/2022, KP51491, exp 11/30/2022, KP51781, exp 01/31/2023, KP52249, exp 01/31/2023, KP52270, exp 01/31/2023, KP52722, exp 01/31/2023, KP52973, exp 01/31/2023, KP53031, exp 01/31/2023, KP53221, exp 12.04.2023, KP53369, exp 01/31/2023", "product_quantity": "N/A", "distribution_pattern": "Nationwide in the USA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2021-03-22", "center_classification_date": "2021-06-10", "report_date": "2021-04-21", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Liraglutide", "matched_compound_slugs": "liraglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0618-2021", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Novo Nordisk Inc", "state": "NJ", "product_description": "Saxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen, Sample. Not for Resale., Rx only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-2800-90 (Pen), NDC 0169-2800-97 (Kit)", "reason_for_recall": "Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.", "code_info": "K1620A1 (Kit); KZFH714 (Pen) exp 05/31/2022; B2020A (Kit); JZFF482 (Pen) exp 11/30/2021; I2320A (Kit); KZFH714 (Pen) exp 05/31/2022; H1020A (Kit); KZFH714 (Pen) exp 05/31/2022; J0520A(Kit); KZFH714 (Pen) exp 05/31/2022", "product_quantity": "N/A", "distribution_pattern": "Nationwide in the USA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2021-03-22", "center_classification_date": "2021-06-10", "report_date": "2021-04-21", "fda_matched_an_approved_listing": true }, { "matched_search_terms": "Liraglutide", "matched_compound_slugs": "liraglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0622-2021", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Novo Nordisk Inc", "state": "NJ", "product_description": "ViCTOZA (liraglutide) injection, 18 mg/3 mL (6 mg/mL), contains: 1 Victoza Pen, Sample Not for Resale, Rx only, Manufactured by: Novo Nordisk A/S, Bagesvaerd, Denmark NDC 0169-4060-90 (Pen), 0169-4060-99 (Kit)", "reason_for_recall": "Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.", "code_info": "I2419A (Kit); JS68K86 (Pen) exp 05/31/2021", "product_quantity": "N/A", "distribution_pattern": "Nationwide in the USA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2021-03-22", "center_classification_date": "2021-06-10", "report_date": "2021-04-21", "fda_matched_an_approved_listing": true }, { "matched_search_terms": "Liraglutide", "matched_compound_slugs": "liraglutide", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0623-2021", "classification_fda": "Class I", "classification": "class-i", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Novo Nordisk Inc", "state": "NJ", "product_description": "Xultophy 100/3.6 (insulin degludec and liraglutide injection), 100 units/mL and 3.6 mg/mL, 3 mL Prefilled Pen, SAMPLE, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-2911-90 (Pen) NDC 0169-2911-97 (Kit)", "reason_for_recall": "Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.", "code_info": "JP54291, exp 06/20/2021", "product_quantity": "N/A", "distribution_pattern": "Nationwide in the USA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2021-03-22", "center_classification_date": "2021-06-10", "report_date": "2021-04-21", "fda_matched_an_approved_listing": true }, { "matched_search_terms": "CJC-1295", "matched_compound_slugs": "cjc-1295", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0128-2021", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Advanced Nutriceuticals, LLC", "state": "IN", "product_description": "CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN", "reason_for_recall": "Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.", "code_info": "Lot #1029202004, Exp 11/29/2020; Lot #1102202001, 102202009, Exp 12/08/2020; Lot #1105202009, Exp 12/20/2020; Lot #1110202003, Exp 12/10/2020; Lot #1112202004, Exp 12/12/2020", "product_quantity": "6 vials", "distribution_pattern": "CA, CO, FL, IN, KY, OH, TX", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2020-11-30", "center_classification_date": "2020-12-11", "report_date": "2020-12-23", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "PT-141", "matched_compound_slugs": "pt-141", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0130-2021", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Advanced Nutriceuticals, LLC", "state": "IN", "product_description": "PT-141, 10 MG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN", "reason_for_recall": "Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.", "code_info": "Lot #1112202006, Exp 12/12/2020", "product_quantity": "1 vial", "distribution_pattern": "CA, CO, FL, IN, KY, OH, TX", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2020-11-30", "center_classification_date": "2020-12-11", "report_date": "2020-12-23", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "AOD-9604", "matched_compound_slugs": "aod-9604", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0131-2021", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Advanced Nutriceuticals, LLC", "state": "IN", "product_description": "AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indianapolis, IN", "reason_for_recall": "Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.", "code_info": "Lot #1029202003, Exp 11/29/2020; Lot #1110202002, Exp 12/10/2020; Lot #1112202001, Exp 12/12/2020", "product_quantity": "3 vials", "distribution_pattern": "CA, CO, FL, IN, KY, OH, TX", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2020-11-30", "center_classification_date": "2020-12-11", "report_date": "2020-12-23", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "BPC-157", "matched_compound_slugs": "bpc-157", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0132-2021", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Advanced Nutriceuticals, LLC", "state": "IN", "product_description": "BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN", "reason_for_recall": "Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.", "code_info": "Lot #1102202009, Exp 12/08/2020; Lot #1105202009, Exp 12/20/2020; Lot #1110202001, Exp 12/15/2020; Lot #1112202004, Exp 12/12/2020", "product_quantity": "4 vials", "distribution_pattern": "CA, CO, FL, IN, KY, OH, TX", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2020-11-30", "center_classification_date": "2020-12-11", "report_date": "2020-12-23", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Ipamorelin", "matched_compound_slugs": "ipamorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0134-2021", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Advanced Nutriceuticals, LLC", "state": "IN", "product_description": "IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN", "reason_for_recall": "Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.", "code_info": "Lot # 1029202005,Exp 11/29/2020; Lot #1102202014, Exp 12/08/2020; Lot #1112202002, Exp 12/12/2020", "product_quantity": "3 vials", "distribution_pattern": "CA, CO, FL, IN, KY, OH, TX", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2020-11-30", "center_classification_date": "2020-12-11", "report_date": "2020-12-23", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "DSIP", "matched_compound_slugs": "dsip", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0138-2021", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Advanced Nutriceuticals, LLC", "state": "IN", "product_description": "DSIP, 1000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN", "reason_for_recall": "Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.", "code_info": "Lot #1111202002, Exp 12/11/2020", "product_quantity": "1 vial", "distribution_pattern": "CA, CO, FL, IN, KY, OH, TX", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2020-11-30", "center_classification_date": "2020-12-11", "report_date": "2020-12-23", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "TB-500", "matched_compound_slugs": "tb-500", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0140-2021", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Advanced Nutriceuticals, LLC", "state": "IN", "product_description": "THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN", "reason_for_recall": "Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.", "code_info": "Lot #1110202005, Exp 12/10/2020; Lot #1102202015, Exp 12/08/2020; Lot #1105202009, Exp 12/20/2020", "product_quantity": "3 vials", "distribution_pattern": "CA, CO, FL, IN, KY, OH, TX", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2020-11-30", "center_classification_date": "2020-12-11", "report_date": "2020-12-23", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "GHK-Cu", "matched_compound_slugs": "ghk-cu", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0141-2021", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Advanced Nutriceuticals, LLC", "state": "IN", "product_description": "GHK-CU, 10 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN", "reason_for_recall": "Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.", "code_info": "Lot #1030202010, Exp 11/30/2020", "product_quantity": "1 vial", "distribution_pattern": "CA, CO, FL, IN, KY, OH, TX", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2020-11-30", "center_classification_date": "2020-12-11", "report_date": "2020-12-23", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "LL-37", "matched_compound_slugs": "ll-37", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0143-2021", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Advanced Nutriceuticals, LLC", "state": "IN", "product_description": "LL-37, 2000 MCG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN", "reason_for_recall": "Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.", "code_info": "Lot #1105202006, Exp 12/18/2020", "product_quantity": "1 vial", "distribution_pattern": "CA, CO, FL, IN, KY, OH, TX", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2020-11-30", "center_classification_date": "2020-12-11", "report_date": "2020-12-23", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0953-2020", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical", "state": "CA", "product_description": "Glutathione Injection,GLUTATHIONE 200MG/ML INJECTABLE For IV, IM Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1231-3", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot #: 10212019+53138, Exp 11/19/2020; 10302019+53172, Exp 1/28/2020; 11122019+53225, Exp 2/10/2020", "product_quantity": "N/A", "distribution_pattern": "U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2020-01-15", "center_classification_date": "2020-03-05", "report_date": "2020-03-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "NAD+", "matched_compound_slugs": "nad-plus", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0977-2020", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical", "state": "CA", "product_description": "Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF) 50 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 10 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0306-1", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot #: 08282019+52850, Exp 1/24/2020; 10102019+53094, Exp 2/28/2020; 10312019+53174, Exp 3/28/2020", "product_quantity": "N/A", "distribution_pattern": "U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2020-01-15", "center_classification_date": "2020-03-05", "report_date": "2020-03-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "NAD+", "matched_compound_slugs": "nad-plus", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0978-2020", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical", "state": "CA", "product_description": "Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF) 20 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 10 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0336-1", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot #: 10082019+53069, Exp 2/28/2020", "product_quantity": "N/A", "distribution_pattern": "U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2020-01-15", "center_classification_date": "2020-03-05", "report_date": "2020-03-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "BPC-157", "matched_compound_slugs": "bpc-157", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0679-2020", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Assurance Infusion", "state": "TX", "product_description": "BPC-157 2000 mcg/mL in 5 mL vials Assurance Infusion (713) 533-8800", "reason_for_recall": "Lack of sterility assurance.", "code_info": "Lots: 11132019@15 Exp. 02/11/2020; 12112019@25 Exp. 02/13/2020; 11202019@9 Exp. 02/13/2020", "product_quantity": "28 vials", "distribution_pattern": "Nationwide within the United States", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2019-12-20", "center_classification_date": "2020-01-13", "report_date": "2020-01-22", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "CJC-1295; Ipamorelin", "matched_compound_slugs": "cjc-1295; ipamorelin", "includes_class_comparator": false, "search_match_count": 2, "recall_number": "D-0720-2020", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Assurance Infusion", "state": "TX", "product_description": "CJC-1295 2000 mcg/Ipamorelin 2000 mcg/mL Inj. in 2 mL vial Assurance Infusion (713) 533-8800", "reason_for_recall": "Lack of sterility assurance.", "code_info": "Lots: 08212019@29 Exp. 02/17/2020; 07152019@12 Exp. 01/11/2020; 07082019@26 Exp. 01/04/2020;", "product_quantity": "19 vials", "distribution_pattern": "Nationwide within the United States", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2019-12-20", "center_classification_date": "2020-01-13", "report_date": "2020-01-22", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Ipamorelin", "matched_compound_slugs": "ipamorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0748-2020", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Assurance Infusion", "state": "TX", "product_description": "IPAMORELIN 2000MCG/ML INJ in 2 mL vial Assurance Infusion (713) 533-8800", "reason_for_recall": "Lack of sterility assurance.", "code_info": "Lots: 07162019@20 Exp. 01/12/2020; 12102019@17 Exp. 06/07/2020; 07162019@20 Exp. 01/12/2020", "product_quantity": "5 vials", "distribution_pattern": "Nationwide within the United States", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2019-12-20", "center_classification_date": "2020-01-13", "report_date": "2020-01-22", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0200-2020", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy", "state": "AZ", "product_description": "S-ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, 10ML dropper bottle, RX only, Red Mountain Compounding RX", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot #: S07222019DH@09, Exp 8/22/19", "product_quantity": "2x 10 ml bottles", "distribution_pattern": "Nationwide in the USA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2019-08-12", "center_classification_date": "2019-11-05", "report_date": "2019-11-13", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0223-2020", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy", "state": "AZ", "product_description": "S-GLUTATHIONE 200MG/3ML (PF) INHALATION SOLN, 3ML Prefilled Syringe, Red Mountain Compounding RX", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot #: S07262019DH@02, Exp 8/26/19", "product_quantity": "1, 3 ml prefilled syringe", "distribution_pattern": "Nationwide in the USA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2019-08-12", "center_classification_date": "2019-11-05", "report_date": "2019-11-13", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0224-2020", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy", "state": "AZ", "product_description": "S-GLUTATHIONE 200MG/ML MDV, packaged in a) 12 ML b) 30 ml, glass vial, Red Mountain Compounding RX", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot #: a) S06252019DH@12, Exp 9/25/19; S07162019DT@02, Exp 10/16/19; b) S05162019DH@19, Exp 8/16/19; S05072019DT@08, Exp 8/7/19; S05082019DT@07, Exp 8/8/19; S05282019DT@08, Exp 8/28/19; S05312019DT@05, Exp 8/31/19; S06182019DH@11, Exp 9/18/19; S06242019DH@09, Exp 9/24/19; S07102019DT@06, Exp 10/10/19; S07162019DT@03, Exp 10/16/19; S07222019DH@10, Exp 10/22/19;", "product_quantity": "2x12 ML and 79x30 ML vials", "distribution_pattern": "Nationwide in the USA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2019-08-12", "center_classification_date": "2019-11-05", "report_date": "2019-11-13", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0159-2020", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Innoveix Pharmaceuticals Inc", "state": "TX", "product_description": "Lyophilized Sermorelin w/ GHRP2 3 mg For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910", "reason_for_recall": "Lack of Sterility Assurance.", "code_info": "Lots: SER 925 Exp. 11/4/19; SER 930 Exp. 11/18/19; SER 935 Exp. 2/21/20; SER 400 Exp. 4/1/20; SER 405 Exp. 5/11/20; SER 410 Exp. 7/15/20", "product_quantity": "1747 vials", "distribution_pattern": "Nationwide within the United States", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2019-10-10", "center_classification_date": "2019-10-28", "report_date": "2019-11-06", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0053-2020", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "KRS Global Biotechnology, Inc", "state": "FL", "product_description": "Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321674186", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lots remaining within expiry.", "product_quantity": "402 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2019-09-12", "center_classification_date": "2019-10-01", "report_date": "2019-10-09", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "NAD+", "matched_compound_slugs": "nad-plus", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0079-2020", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "KRS Global Biotechnology, Inc", "state": "FL", "product_description": "Nicotinamide Adenine Dinucleotide (PF), Lyophilized-For IV Use-Single Dose Vial, 500 mg/Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678103", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lots remaining within expiry.", "product_quantity": "4390 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2019-09-12", "center_classification_date": "2019-10-01", "report_date": "2019-10-09", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0093-2020", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "KRS Global Biotechnology, Inc", "state": "FL", "product_description": "Sermorelin Acetate, 9 mg / GHRP-2, 5.4 mg/vial Lyophilized-for SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674047", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lots remaining within expiry.", "product_quantity": "258 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2019-09-12", "center_classification_date": "2019-10-01", "report_date": "2019-10-09", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0094-2020", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "KRS Global Biotechnology, Inc", "state": "FL", "product_description": "Sermorelin Acetate, 3 mg/mL/GHRP6, 1.8 mg/mL/GHRP2, 1.8 mg/mL, 3 mL Injections-CART-Item#: 73752, For SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lots remaining within expiry.", "product_quantity": "218 cartridges", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2019-09-12", "center_classification_date": "2019-10-01", "report_date": "2019-10-09", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0095-2020", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "KRS Global Biotechnology, Inc", "state": "FL", "product_description": "Sermorelin, 3 mg/GHRP6, 3 mg/GHRP2, 3 mg/Vial, For SC Use, Vial-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673816", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lots remaining within expiry.", "product_quantity": "647 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2019-09-12", "center_classification_date": "2019-10-01", "report_date": "2019-10-09", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0096-2020", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "KRS Global Biotechnology, Inc", "state": "FL", "product_description": "Sermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673589", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lots remaining within expiry.", "product_quantity": "246 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2019-09-12", "center_classification_date": "2019-10-01", "report_date": "2019-10-09", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0097-2020", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "KRS Global Biotechnology, Inc", "state": "FL", "product_description": "Sermorelin Acetate 9 mg/ 3 mL (3 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lots remaining within expiry.", "product_quantity": "152 cartridges", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2019-09-12", "center_classification_date": "2019-10-01", "report_date": "2019-10-09", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0098-2020", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "KRS Global Biotechnology, Inc", "state": "FL", "product_description": "Sermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321601122", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lots remaining within expiry.", "product_quantity": "64 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2019-09-12", "center_classification_date": "2019-10-01", "report_date": "2019-10-09", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0099-2020", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "KRS Global Biotechnology, Inc", "state": "FL", "product_description": "Sermorelin Acetate 9 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673588", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lots remaining within expiry.", "product_quantity": "341 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2019-09-12", "center_classification_date": "2019-10-01", "report_date": "2019-10-09", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0100-2020", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "KRS Global Biotechnology, Inc", "state": "FL", "product_description": "Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674092", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lots remaining within expiry.", "product_quantity": "120 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2019-09-12", "center_classification_date": "2019-10-01", "report_date": "2019-10-09", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1662-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "RXQ Compounding LLC", "state": "OH", "product_description": "GLUTATHIONE 200MG/ML (PFV) INJECTION SOLN, 10 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0971-81", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lots within expiry", "product_quantity": "N/A", "distribution_pattern": "Nationwide USA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2019-06-19", "center_classification_date": "2019-08-08", "report_date": "2019-08-14", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1663-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "RXQ Compounding LLC", "state": "OH", "product_description": "GLUTATHIONE 200MG/ML (MDV) INJECTION SOLN, 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0906-30", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lots within expiry", "product_quantity": "N/A", "distribution_pattern": "Nationwide USA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2019-06-19", "center_classification_date": "2019-08-08", "report_date": "2019-08-14", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1484-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "First Pharma Associates LLC dba Riverpoint Pharmacy", "state": "WA", "product_description": "Glutathione 100 mg/mL Inhalation Solution (PF), 45 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252", "reason_for_recall": "Lack of Assurance of Sterility.", "code_info": "Lot #: 06172019@3, Exp. 08/18/2019", "product_quantity": "45 mL", "distribution_pattern": "ID, WA only", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2019-06-26", "center_classification_date": "2019-07-11", "report_date": "2019-07-17", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Ipamorelin", "matched_compound_slugs": "ipamorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1327-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Pharm D Solutions, LLC", "state": "TX", "product_description": "Ipamorelin Acetate 9 mg/9mL Injectable vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846", "reason_for_recall": "Lack of Sterility Assurance.", "code_info": "Lot #: 05022019:50 Exp. 10/29/2019; 05082019:91 Exp. 06/08/2019", "product_quantity": "11 vials", "distribution_pattern": "Nationwide within the United States", "voluntary_or_mandated": "FDA Mandated", "recall_initiation_date": "2019-05-23", "center_classification_date": "2019-06-07", "report_date": "2019-06-19", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Ipamorelin; Sermorelin", "matched_compound_slugs": "ipamorelin; sermorelin", "includes_class_comparator": false, "search_match_count": 2, "recall_number": "D-1330-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Pharm D Solutions, LLC", "state": "TX", "product_description": "Sermorelin/Ipamorelin 18 mg/15 mg, 10mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846", "reason_for_recall": "Lack of Sterility Assurance.", "code_info": "Lot #: 04162019:48 Exp. 10/13/2019; 04302019:70 Exp. 10/27/2019; 05022019:34 Exp. 10/29/2019", "product_quantity": "24 vials", "distribution_pattern": "Nationwide within the United States", "voluntary_or_mandated": "FDA Mandated", "recall_initiation_date": "2019-05-23", "center_classification_date": "2019-06-07", "report_date": "2019-06-19", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1331-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Pharm D Solutions, LLC", "state": "TX", "product_description": "Sermorelin/GHRP-2 9 mg/9 mg vials Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846", "reason_for_recall": "Lack of Sterility Assurance.", "code_info": "Lot #: 05082019:92 Exp. 06/04/2019", "product_quantity": "6 vials", "distribution_pattern": "Nationwide within the United States", "voluntary_or_mandated": "FDA Mandated", "recall_initiation_date": "2019-05-23", "center_classification_date": "2019-06-07", "report_date": "2019-06-19", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1332-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Pharm D Solutions, LLC", "state": "TX", "product_description": "Sermorelin/GHRP-2 9 mg/6 mg vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846", "reason_for_recall": "Lack of Sterility Assurance.", "code_info": "Lot #: 03052019:43 Exp. 08/31/2019; 04042019:15 Exp. 10/01/2019; 04172019:08 Exp. 08/31/2019; 05022019:47 Exp. 10/30/2019; 05082019:78 Exp. 06/04/2019", "product_quantity": "66 vials", "distribution_pattern": "Nationwide within the United States", "voluntary_or_mandated": "FDA Mandated", "recall_initiation_date": "2019-05-23", "center_classification_date": "2019-06-07", "report_date": "2019-06-19", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1333-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Pharm D Solutions, LLC", "state": "TX", "product_description": "Sermorelin/GHRP-2 & 6 (3-3-3 MG) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846", "reason_for_recall": "Lack of Sterility Assurance.", "code_info": "Lot #: 12062018:17 Exp. 06/04/2019", "product_quantity": "100 vials", "distribution_pattern": "Nationwide within the United States", "voluntary_or_mandated": "FDA Mandated", "recall_initiation_date": "2019-05-23", "center_classification_date": "2019-06-07", "report_date": "2019-06-19", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1334-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Pharm D Solutions, LLC", "state": "TX", "product_description": "Sermorelin/GHRP-2 &6 (9-9-9-mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846", "reason_for_recall": "Lack of Sterility Assurance.", "code_info": "Lot #: 05032019:29 Exp. 11/02/2019", "product_quantity": "1 vial", "distribution_pattern": "Nationwide within the United States", "voluntary_or_mandated": "FDA Mandated", "recall_initiation_date": "2019-05-23", "center_classification_date": "2019-06-07", "report_date": "2019-06-19", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1335-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Pharm D Solutions, LLC", "state": "TX", "product_description": "Sermorelin/GHRP-2 &6 (9-9-9 mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846", "reason_for_recall": "Lack of Sterility Assurance.", "code_info": "Lot #: 02182019:79 Exp. 08/17/2019; 04162019:86 Exp. 10/13/2019", "product_quantity": "25 vials", "distribution_pattern": "Nationwide within the United States", "voluntary_or_mandated": "FDA Mandated", "recall_initiation_date": "2019-05-23", "center_classification_date": "2019-06-07", "report_date": "2019-06-19", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1255-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Customceutical Compounding", "state": "AZ", "product_description": "Glutathione 200mg/mL inj. a) 10 ML and b) 12 ML MULTIDOSE VIAL MDV Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272", "reason_for_recall": "Lack of assurance of sterility for injectables and solutions intended to be sterile.", "code_info": "Lot #: 02132019@25, Exp 5/14/19", "product_quantity": "4 vials", "distribution_pattern": "U.S.A. Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2019-04-08", "center_classification_date": "2019-04-30", "report_date": "2019-05-08", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1175-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy", "state": "TN", "product_description": "Sermorelin 0.3 mg/0.5 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.", "reason_for_recall": "Lack of sterility assurance.", "code_info": "All Lots", "product_quantity": "22 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2019-04-02", "center_classification_date": "2019-04-18", "report_date": "2019-04-24", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1176-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy", "state": "TN", "product_description": "Sermorelin 0.4 mg/0.5 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.", "reason_for_recall": "Lack of sterility assurance.", "code_info": "All Lots", "product_quantity": "6 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2019-04-02", "center_classification_date": "2019-04-18", "report_date": "2019-04-24", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0445-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Promise Pharmacy, LLC", "state": "FL", "product_description": "Glutathione Injection, 200 mg/mL, 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684", "reason_for_recall": "Lack of sterility assurance.", "code_info": "Lots: 09172018@7 BUD: 12/16/2018; 10292018@2 BUD: 1/27/2019", "product_quantity": "288 10 ml vials", "distribution_pattern": "Nationwide in the USA.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-12-17", "center_classification_date": "2019-02-08", "report_date": "2019-02-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "TB-500", "matched_compound_slugs": "tb-500", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0447-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Promise Pharmacy, LLC", "state": "FL", "product_description": "Thymosin Beta-4, 15 mg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684", "reason_for_recall": "Lack of sterility assurance.", "code_info": "Lots: 08302018@8 BUD: 2/26/2019; 10012018@2 BUD: 3/30/2019; 07052018@2 BUD: 01/01/2019", "product_quantity": "94 vials", "distribution_pattern": "Nationwide in the USA.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-12-17", "center_classification_date": "2019-02-08", "report_date": "2019-02-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0448-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Promise Pharmacy, LLC", "state": "FL", "product_description": "Sermorelin Theanine/GHRP2, 15 mg/75 mg/5.4 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684", "reason_for_recall": "Lack of sterility assurance.", "code_info": "Lot: 07202018@4 BUD: 1/16/2019", "product_quantity": "25 vials", "distribution_pattern": "Nationwide in the USA.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-12-17", "center_classification_date": "2019-02-08", "report_date": "2019-02-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0449-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Promise Pharmacy, LLC", "state": "FL", "product_description": "Sermorelin 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684", "reason_for_recall": "Lack of sterility assurance.", "code_info": "Lots: 06182018@2 BUD: 12/15/2018; 08212018@12 BUD: 2/17/2019; 09212018@15 BUD: 3/20/2019; 11132018@1 BUD: 5/12/2019", "product_quantity": "255 vials", "distribution_pattern": "Nationwide in the USA.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-12-17", "center_classification_date": "2019-02-08", "report_date": "2019-02-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0450-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Promise Pharmacy, LLC", "state": "FL", "product_description": "Sermorelin/GHRP2/GHRP6, 9 mg/9 mg/9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684", "reason_for_recall": "Lack of sterility assurance.", "code_info": "Lots: 07102018@3 BUD: 1/6/2019 08302018@9 BUD: 2/26/2019", "product_quantity": "341 vials", "distribution_pattern": "Nationwide in the USA.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-12-17", "center_classification_date": "2019-02-08", "report_date": "2019-02-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0451-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Promise Pharmacy, LLC", "state": "FL", "product_description": "Sermorelin/GHRP2/GHRP6 6mg/3mg/3mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684", "reason_for_recall": "Lack of sterility assurance.", "code_info": "Lots: 08302018@13 BUD: 2/26/2019; 09212018@14 BUD: 3/20/2019", "product_quantity": "296 vials", "distribution_pattern": "Nationwide in the USA.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-12-17", "center_classification_date": "2019-02-08", "report_date": "2019-02-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Ipamorelin", "matched_compound_slugs": "ipamorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0452-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Promise Pharmacy, LLC", "state": "FL", "product_description": "Ipamorelin+Modified GRF 1-29, 9 mg/5mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684", "reason_for_recall": "Lack of sterility assurance.", "code_info": "Lots: 07052018@1 BUD: 1/1/2019; 09182018@6 BUD: 3/1/2019; 09212018@10 BUD: 3/4/2019; 10052018@1 BUD: 3/18/2019; 11062018@2 BUD: 4/19/2019", "product_quantity": "927 vials", "distribution_pattern": "Nationwide in the USA.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-12-17", "center_classification_date": "2019-02-08", "report_date": "2019-02-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Ipamorelin", "matched_compound_slugs": "ipamorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0453-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Promise Pharmacy, LLC", "state": "FL", "product_description": "Ipamorelin, 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684", "reason_for_recall": "Lack of sterility assurance.", "code_info": "Lots: 07132018@5 BUD: 1/9/2019; 07302018@32 BUD: 1/26/2019; 09182018@7 BUD: 3/17/2019; 10192018@2 BUD: 4/17/2019", "product_quantity": "416 vials", "distribution_pattern": "Nationwide in the USA.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-12-17", "center_classification_date": "2019-02-08", "report_date": "2019-02-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Ipamorelin; Sermorelin", "matched_compound_slugs": "ipamorelin; sermorelin", "includes_class_comparator": false, "search_match_count": 2, "recall_number": "D-0454-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Promise Pharmacy, LLC", "state": "FL", "product_description": "Ipamorelin+Sermorelin, 15mg/15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684", "reason_for_recall": "Lack of sterility assurance.", "code_info": "09212018@12 BUD: 12/20/2018; 11062018@3 BUD: 6/4/2019", "product_quantity": "139 vials", "distribution_pattern": "Nationwide in the USA.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-12-17", "center_classification_date": "2019-02-08", "report_date": "2019-02-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Ipamorelin", "matched_compound_slugs": "ipamorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0455-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Promise Pharmacy, LLC", "state": "FL", "product_description": "Ipamorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684", "reason_for_recall": "Lack of sterility assurance.", "code_info": "Lots: 09182018@4 BUD: 3/17/2019; 10052018@3 BUD: 4/3/2019; 11132018@3 BUD: 5/12/2019", "product_quantity": "93 vials", "distribution_pattern": "Nationwide in the USA.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-12-17", "center_classification_date": "2019-02-08", "report_date": "2019-02-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "IGF-1 LR3", "matched_compound_slugs": "igf-1-lr3", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0456-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Promise Pharmacy, LLC", "state": "FL", "product_description": "IGF-1 LR3, 620 mcg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684", "reason_for_recall": "Lack of sterility assurance.", "code_info": "Lot: 06282018@3 BUD: 12/25/2018", "product_quantity": "59 vials", "distribution_pattern": "Nationwide in the USA.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-12-17", "center_classification_date": "2019-02-08", "report_date": "2019-02-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Epitalon", "matched_compound_slugs": "epitalon", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0457-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Promise Pharmacy, LLC", "state": "FL", "product_description": "Epithalon, 15mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684", "reason_for_recall": "Lack of sterility assurance.", "code_info": "Lots: 09212018@11 BUD: 12/20/2018; 11132018@4 BUD: 2/11/2019", "product_quantity": "30 vials", "distribution_pattern": "Nationwide in the USA.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-12-17", "center_classification_date": "2019-02-08", "report_date": "2019-02-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "PT-141", "matched_compound_slugs": "pt-141", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0458-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Promise Pharmacy, LLC", "state": "FL", "product_description": "Bremelanotide (PT 141), 20mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684", "reason_for_recall": "Lack of sterility assurance.", "code_info": "Lots: 10192018@4 BUD: 12/18/2019; 11132018@5 BUD: 1/12/2019", "product_quantity": "64 vials", "distribution_pattern": "Nationwide in the USA.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-12-17", "center_classification_date": "2019-02-08", "report_date": "2019-02-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "BPC-157", "matched_compound_slugs": "bpc-157", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0459-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Promise Pharmacy, LLC", "state": "FL", "product_description": "BPC 157, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684", "reason_for_recall": "Lack of sterility assurance.", "code_info": "Lot: 11062018@5 BUD: 2/4/2019", "product_quantity": "37 vials", "distribution_pattern": "Nationwide in the USA.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-12-17", "center_classification_date": "2019-02-08", "report_date": "2019-02-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0463-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Promise Pharmacy, LLC", "state": "FL", "product_description": "Sermorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684", "reason_for_recall": "Lack of sterility assurance.", "code_info": "Lots: 07102018@4 BUD: 1/6/2019; 09142018@6 BUD: 3/13/2019; 10052018@4 BUD: 4/3/2019; 11062018@1 BUD: 5/5/2019", "product_quantity": "266 vials", "distribution_pattern": "Nationwide in the USA.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-12-17", "center_classification_date": "2019-02-08", "report_date": "2019-02-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "IGF-1 LR3", "matched_compound_slugs": "igf-1-lr3", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0464-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Promise Pharmacy, LLC", "state": "FL", "product_description": "IGF-1-LR3, 3 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684", "reason_for_recall": "Lack of sterility assurance.", "code_info": "Lot: 06282018@2 BUD: 12/25/2018", "product_quantity": "59 vials", "distribution_pattern": "Nationwide in the USA.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-12-17", "center_classification_date": "2019-02-08", "report_date": "2019-02-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Melanotan II", "matched_compound_slugs": "melanotan-2", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0465-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Promise Pharmacy, LLC", "state": "FL", "product_description": "Melanotan II, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684", "reason_for_recall": "Lack of sterility assurance.", "code_info": "Lots: 07202018@3 BUD: 1/13/2019; 09212018@13 BUD: 2/28/2019", "product_quantity": "43 vials", "distribution_pattern": "Nationwide in the USA.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-12-17", "center_classification_date": "2019-02-08", "report_date": "2019-02-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "NAD+", "matched_compound_slugs": "nad-plus", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0468-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Promise Pharmacy, LLC", "state": "FL", "product_description": "Nicotinamide Adenine Dinucleotide, 0.5 mg, injection, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684", "reason_for_recall": "Lack of sterility assurance.", "code_info": "Lots: 11062018@13 BUD: 12/21/2018; 11072018@24 BUD: 12/22/2018", "product_quantity": "5 10 mL vials", "distribution_pattern": "Nationwide in the USA.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-12-17", "center_classification_date": "2019-02-08", "report_date": "2019-02-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0394-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Hiers Enterprises, LLC dba Northwest Compounding Pharmacy", "state": "OR", "product_description": "Glutathione liquid, 100mg/ml", "reason_for_recall": "Lack of sterility assurance.", "code_info": "10292018@17", "product_quantity": "60 ml", "distribution_pattern": "Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2019-01-02", "center_classification_date": "2019-01-27", "report_date": "2019-01-09", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0407-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Hiers Enterprises, LLC dba Northwest Compounding Pharmacy", "state": "OR", "product_description": "Glutathione liquid, 200mg/ml, Rx", "reason_for_recall": "Lack of sterility assurance.", "code_info": "10092018@5", "product_quantity": "N/A", "distribution_pattern": "Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2019-01-02", "center_classification_date": "2019-01-27", "report_date": "2019-01-09", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Tesamorelin", "matched_compound_slugs": "tesamorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0223-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Tailor Made Compounding", "state": "KY", "product_description": "Tesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Subcutaneous Injection, Rx Only, Tailor Made Compounding, Nicholasville, KY 40356", "reason_for_recall": "Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration date instead of a 6 month expiration date", "code_info": "Lot, exp: 7101804, 7111807, 7131807, 7151801, 7161804, 7181805, 7191801, 7201803, 7211801, 7221801, 7231805, 7241803, 7251803, 7261802, 7271801, 7281801, 7301805, 7311805, exp 7/19; 8021801, 8031801, 8041801, 8081802, 8091804, 8101803, 8111810, 8121801, 8141801, 8161803, 8171803, 8201801, 8251801, exp 8/19", "product_quantity": "10,280 Vials", "distribution_pattern": "Nationwide USA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-09-28", "center_classification_date": "2018-11-07", "report_date": "2018-11-14", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0154-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Pharm D Solutions, LLC", "state": "TX", "product_description": "Glutathione 200 mg/mL Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1504-30", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot: 08012018:94 Discard by: 1/27/2019", "product_quantity": "4000 milliliters", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-09-10", "center_classification_date": "2018-11-01", "report_date": "2018-11-07", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Ipamorelin; Sermorelin", "matched_compound_slugs": "ipamorelin; sermorelin", "includes_class_comparator": false, "search_match_count": 2, "recall_number": "D-0179-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Pharm D Solutions, LLC", "state": "TX", "product_description": "Sermorelin/Ipamorelin 18 mg/15 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1759-18", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot: 07272018:31 Discard by: 1/23/2019", "product_quantity": "179 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-09-10", "center_classification_date": "2018-11-01", "report_date": "2018-11-07", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0180-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Pharm D Solutions, LLC", "state": "TX", "product_description": "Sermorelin/GHRP-2 6 mg/6 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1727-10", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot: 05012018:48 Discard by: 10/28/2018; 05242018:32 Discard by: 11/20/2018; 06112018:53 Discard by: 12/8/2018", "product_quantity": "409 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-09-10", "center_classification_date": "2018-11-01", "report_date": "2018-11-07", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0181-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Pharm D Solutions, LLC", "state": "TX", "product_description": "Sermorelin/GHRP-2 18 mg/6 mg powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1748-10", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot: 04232018:89 Discard by: 10/15/2018", "product_quantity": "124 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-09-10", "center_classification_date": "2018-11-01", "report_date": "2018-11-07", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0182-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Pharm D Solutions, LLC", "state": "TX", "product_description": "Sermorelin/GHRP-2 9 mg-6 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1728-10", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot: 03202018:06 Discard by: 9/16/2018; 06112018:49 Discard by: 12/8/2018", "product_quantity": "330 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-09-10", "center_classification_date": "2018-11-01", "report_date": "2018-11-07", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0183-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Pharm D Solutions, LLC", "state": "TX", "product_description": "Sermorelin/GHRP-2 9 mg/9 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1715-10", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot: 03202018:46 Discard by: 9/16/2018; 05012018:56 Discard by: 10/28/2018", "product_quantity": "250 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-09-10", "center_classification_date": "2018-11-01", "report_date": "2018-11-07", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0184-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Pharm D Solutions, LLC", "state": "TX", "product_description": "Sermorelin/GHRP-2/GHRP-6 Mannitol 9 mg/9 mg/9 mg/300 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1726-10", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot: 04232018:46 Discard by: 10/13/2018; 06252018:30 Discard by: 12/22/2018; 07232018:10 Discard by: 1/19/2019; 08302018:07 Discard by: 2/25/2019", "product_quantity": "420 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-09-10", "center_classification_date": "2018-11-01", "report_date": "2018-11-07", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0185-2019", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Pharm D Solutions, LLC", "state": "TX", "product_description": "Sermorelin/GHRP-2/Theanine/Mannitol 15 mg/6 mg/75 mg/300 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1731-10", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot: 07062018:05 Discard by: 1/2/2019", "product_quantity": "108 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-09-10", "center_classification_date": "2018-11-01", "report_date": "2018-11-07", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Ipamorelin", "matched_compound_slugs": "ipamorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1153-2018", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Pharmcore Inc.", "state": "FL", "product_description": "Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009", "reason_for_recall": "Lack of assurance of sterility.", "code_info": "Lot: IPA3-17 Exp. 07/2018", "product_quantity": "6 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-08-02", "center_classification_date": "2018-08-28", "report_date": "2018-09-05", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Ipamorelin", "matched_compound_slugs": "ipamorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1155-2018", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Pharmcore Inc.", "state": "FL", "product_description": "Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009", "reason_for_recall": "Lack of assurance of sterility.", "code_info": "Lots: IPA9-15 Exp. 3/31/2019; IPA9-14 Exp. 1/31/2019", "product_quantity": "599 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-08-02", "center_classification_date": "2018-08-28", "report_date": "2018-09-05", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1159-2018", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Auro Pharmacies, Inc.", "state": "CA", "product_description": "Glutathione injectable, 200 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631", "reason_for_recall": "Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.", "code_info": "Lot #: 180716/21, Exp 14-Oct-18", "product_quantity": "183 vials", "distribution_pattern": "Nationwide in USA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-08-21", "center_classification_date": "2018-08-29", "report_date": "2018-09-05", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1056-2018", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Guardian Pharmacy Services", "state": "TX", "product_description": "Glutathione 200 mg/mL 100ml. Rx Only. Packaged in 100 mL MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247", "reason_for_recall": "Lack of sterility assurance.", "code_info": "Lots: 58436:42 Use By: 05/22/2018; 58653:42 Use By: 06/12/2018; 58773:42, 58766:42, Use By: 06/21/2018; 58766:42 Use By: 06/20/2018;", "product_quantity": "2400 100-ml vials", "distribution_pattern": "Texas", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-05-17", "center_classification_date": "2018-08-08", "report_date": "2018-08-15", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1068-2018", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Guardian Pharmacy Services", "state": "TX", "product_description": "Glutathione 200 mg/mL 100 ml. Rx Only. Packaged in 50ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247", "reason_for_recall": "Lack of sterility assurance.", "code_info": "Lot: 58653:42 Use By: 06/12/2018; 58773/58766 Use By: 06/21/2018; 58766:42 Use By: 06/20/2018;", "product_quantity": "100 50-ml vials", "distribution_pattern": "Texas", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-05-17", "center_classification_date": "2018-08-08", "report_date": "2018-08-15", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1070-2018", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Guardian Pharmacy Services", "state": "TX", "product_description": "Glutathione 200 mg/mL 50 ml MDV. Rx Only. Packaged in 50 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247", "reason_for_recall": "Lack of sterility assurance.", "code_info": "Lot: 59097:42 Use By: 07/23/2018", "product_quantity": "100 50-ml vials", "distribution_pattern": "Texas", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-05-17", "center_classification_date": "2018-08-08", "report_date": "2018-08-15", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0923-2018", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "La Vita Compounding Pharmacy, LLC", "state": "CA", "product_description": "Glutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water), 30 mL vial, Rx only, la VITA Compounding Pharmacy, 858.453.2500", "reason_for_recall": "Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.", "code_info": "Lot #: 144326@3, Exp 07/10/2018; 145953@2, Exp 08/05/2018", "product_quantity": "191 vials", "distribution_pattern": "Product was distributed to patients via patient specific prescription only in CA.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-06-25", "center_classification_date": "2018-07-13", "report_date": "2018-07-25", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0638-2018", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Partell Specialty Pharmacy", "state": "NV", "product_description": "Glutathione 200mg/mL, 10mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800", "reason_for_recall": "Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.", "code_info": "Lot#: 20180219@58, BUD 05/20/2018; 20180131@15, BUD 05/01/2018; 20180116@9, BUD 04/14/2018; 20180103@5, BUD 04/03/2018.", "product_quantity": "four vials", "distribution_pattern": "NV only", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-03-22", "center_classification_date": "2018-04-17", "report_date": "2018-04-25", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0592-2018", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "American Pharmaceutical Ingredients LLC", "state": "MI", "product_description": "Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 58597-8092-4) API American Pharmaceutical Ingredients", "reason_for_recall": "Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.", "code_info": "Lots: 071916-1, Exp. 07/08/2018; 080516-1, 080516-2, Exp. 07/22/2018; 101216-1, 011917C-1, Exp. 09/15/2018;", "product_quantity": "1460 GM", "distribution_pattern": "Nationwide in the USA.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-03-07", "center_classification_date": "2018-03-12", "report_date": "2018-03-21", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0324-2018", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Flawless Beauty LLC", "state": "NJ", "product_description": "Relumins Advanced Glutathione kits, 900 mg vials, 1500 mg vials and 3000 mg vials", "reason_for_recall": "Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.", "code_info": "all lots", "product_quantity": "N/A", "distribution_pattern": "Product was distributed U.S.A. nationwide.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-01-19", "center_classification_date": "2018-02-05", "report_date": "2018-02-14", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0328-2018", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Flawless Beauty LLC", "state": "NJ", "product_description": "Tationil Glutathione, 600 mg/ 4 mL, polvere e solvente per soluzione iniettabile, Teofarma, s.r.l.", "reason_for_recall": "Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.", "code_info": "all lots", "product_quantity": "N/A", "distribution_pattern": "Product was distributed U.S.A. nationwide.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-01-19", "center_classification_date": "2018-02-05", "report_date": "2018-02-14", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0330-2018", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Flawless Beauty LLC", "state": "NJ", "product_description": "Reiki Glutathione Whitening kits", "reason_for_recall": "Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.", "code_info": "all lots", "product_quantity": "N/A", "distribution_pattern": "Product was distributed U.S.A. nationwide.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-01-19", "center_classification_date": "2018-02-05", "report_date": "2018-02-14", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0334-2018", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Flawless Beauty LLC", "state": "NJ", "product_description": "Saluta Glutathione Whitening kits, packaged in 600 mg, 1200 mg and 1800 mg glass vials, Manufactured by: Shandong Luye Pharmaceutical Co, Ltd, Yantai, Shandong. PRC", "reason_for_recall": "Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.", "code_info": "all lots", "product_quantity": "N/A", "distribution_pattern": "Product was distributed U.S.A. nationwide.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-01-19", "center_classification_date": "2018-02-05", "report_date": "2018-02-14", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0335-2018", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Flawless Beauty LLC", "state": "NJ", "product_description": "TAD Glutathione Whitening Kits lyophilized powder for injection, 600 mg vials, 10 vials + 10 amps x 4 mL, Manufactured by: Biomedica Foscama Industria, Ferentino, Italy", "reason_for_recall": "Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.", "code_info": "all lots", "product_quantity": "N/A", "distribution_pattern": "Product was distributed U.S.A. nationwide.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2018-01-19", "center_classification_date": "2018-02-05", "report_date": "2018-02-14", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "NAD+", "matched_compound_slugs": "nad-plus", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0185-2018", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "KRS Global Biotechnology, Inc", "state": "FL", "product_description": "Nicotinamide Adenine Dinucleotide 500 mg packaged in vials, Lyophilized-For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.", "reason_for_recall": "Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.", "code_info": "Lot: 06062017@3 BUD: 12/3/2017", "product_quantity": "2,535 vials", "distribution_pattern": "Nationwide in the USA, Bermuda, and New Zealand", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2017-11-16", "center_classification_date": "2018-01-08", "report_date": "2018-01-17", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0193-2018", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "KRS Global Biotechnology, Inc", "state": "FL", "product_description": "Sermorelin 500 mcg Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.", "reason_for_recall": "Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.", "code_info": "Lot: 07112017@32 BUD: 1/7/2018", "product_quantity": "3,000 tablets", "distribution_pattern": "Nationwide in the USA, Bermuda, and New Zealand", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2017-11-16", "center_classification_date": "2018-01-08", "report_date": "2018-01-17", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0194-2018", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "KRS Global Biotechnology, Inc", "state": "FL", "product_description": "Sermorelin, 3 mg/ GHRP6, 1.8 mg/ GHRP2, 1.8 mg/mL in 3 mL Cartridge, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.", "reason_for_recall": "Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.", "code_info": "Lot: 10122017@8 BUD: 2/9/2018", "product_quantity": "80 cartridges", "distribution_pattern": "Nationwide in the USA, Bermuda, and New Zealand", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2017-11-16", "center_classification_date": "2018-01-08", "report_date": "2018-01-17", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0195-2018", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "KRS Global Biotechnology, Inc", "state": "FL", "product_description": "Sermorelin, 3 mg/ GHRP6, 3 mg/GHRP2, 3 mg, Vial - Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.", "reason_for_recall": "Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.", "code_info": "Lots: 06162017@12 BUD: 12/13/2017; 08042017@1 BUD: 1/31/2018", "product_quantity": "597 vials", "distribution_pattern": "Nationwide in the USA, Bermuda, and New Zealand", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2017-11-16", "center_classification_date": "2018-01-08", "report_date": "2018-01-17", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0196-2018", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "KRS Global Biotechnology, Inc", "state": "FL", "product_description": "Sermorelin Acetate 3 mg/ GHRP6 3 mg, Lyophilized Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.", "reason_for_recall": "Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.", "code_info": "Lot: 06272017@4 BUD: 12/24/2017", "product_quantity": "157 vials", "distribution_pattern": "Nationwide in the USA, Bermuda, and New Zealand", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2017-11-16", "center_classification_date": "2018-01-08", "report_date": "2018-01-17", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1146-2017", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Bella Pharmaceuticals, Inc.", "state": "IL", "product_description": "PF-Glutathione 200mg/ml, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 1 (877) BELLA.", "reason_for_recall": "Lack of Assurance of Sterility.", "code_info": "Lot #: 070617GL, Exp. 1/6/18", "product_quantity": "82 vials", "distribution_pattern": "Nationwide within USA", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2017-08-15", "center_classification_date": "2017-09-12", "report_date": "2017-09-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0765-2017", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Key Pharmacy and Compounding Center", "state": "WA", "product_description": "GLUTATHIONE INH *PV* 200MG/ML SOLN, Inhalation Solution, 200mg/mL, Rx only, 4mL Plastic/Multiple Dose vial, Prepared by Key Compounding Pharmacy", "reason_for_recall": "Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.", "code_info": "Lot # 02-20-2017@8, Exp 4/21/2017.", "product_quantity": "240 mL", "distribution_pattern": "Distributed nationwide in U.S.A., Australia and Canada.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2017-04-18", "center_classification_date": "2017-05-17", "report_date": "2017-05-24", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0260-2017", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Tri-Coast Pharmacy", "state": "FL", "product_description": "Glutathione 200 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06082016A (09/06/2016), 07052016C (10/03/2016), 08082016A (11/06/2016), 09132016D (12/12/2016), 10262016A (01/24/2016).", "product_quantity": "367 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2016-11-17", "center_classification_date": "2017-01-04", "report_date": "2017-01-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0287-2017", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Tri-Coast Pharmacy", "state": "FL", "product_description": "Sermorelin Acetate 6 mg. Compounded by Tri-Coast Pharmacy", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06062016D (12/03/2016), 08022016A (01/29/2017).", "product_quantity": "260 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2016-11-17", "center_classification_date": "2017-01-04", "report_date": "2017-01-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0288-2017", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Tri-Coast Pharmacy", "state": "FL", "product_description": "Sermorelin Acetate 9 mg. Compounded by Tri-Coast Pharmacy", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 08022016B (01/29/2017).", "product_quantity": "54 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2016-11-17", "center_classification_date": "2017-01-04", "report_date": "2017-01-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0289-2017", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Tri-Coast Pharmacy", "state": "FL", "product_description": "Sermorelin Acetate 15 mg. Compounded by Tri-Coast Pharmacy", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 08152016B (02/11/2017).", "product_quantity": "91 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2016-11-17", "center_classification_date": "2017-01-04", "report_date": "2017-01-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0290-2017", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Tri-Coast Pharmacy", "state": "FL", "product_description": "Sermorelin Forte 6 mg (Sermorelin Acetate 6 mg/GHRP-6 3 mg). Compounded by Tri-Coast Pharmacy", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 10192016A (04/17/2017).", "product_quantity": "7 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2016-11-17", "center_classification_date": "2017-01-04", "report_date": "2017-01-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0291-2017", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Tri-Coast Pharmacy", "state": "FL", "product_description": "Sermorelin Forte 12 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg). Compounded by Tri-Coast Pharmacy", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06152016C (12/12/2016), 10242016C (04/22/2017).", "product_quantity": "188 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2016-11-17", "center_classification_date": "2017-01-04", "report_date": "2017-01-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0292-2017", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Tri-Coast Pharmacy", "state": "FL", "product_description": "Sermorelin Forte Plus 18 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg/GHRP-2 6 mg). Compounded by Tri-Coast Pharmacy", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05252016C (11/21/2016), 07252016B (01/21/2017), 09192016B (03/18/2016).", "product_quantity": "441 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2016-11-17", "center_classification_date": "2017-01-04", "report_date": "2017-01-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0293-2017", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Tri-Coast Pharmacy", "state": "FL", "product_description": "Sermorelin Forte Plus 27 mg (Sermorelin Acetate 9 mg/GHRP-6 9 mg/GHRP-2 9 mg). Compounded by Tri-Coast Pharmacy", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05252016B (11/21/2016), 06232016B (12/20/2016), 07152016B (01/11/2017), 08262016D (01/30/2017), 08152016A (01/30/2017), 08022016C (01/29/2017), 09282016C (03/27/2017), 10192016C (04/17/2016), 10252016B (04/23/2017).", "product_quantity": "2116 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2016-11-17", "center_classification_date": "2017-01-04", "report_date": "2017-01-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0294-2017", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Tri-Coast Pharmacy", "state": "FL", "product_description": "Sermorelin GT (Sermorelin Acetate 15 mg/GHRP-2 5.4 mg/Theanine (L) 75 mg). Compounded by Tri-Coast Pharmacy", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06152016B (12/12/2016), 07252016C (01/21/2017), 08262016C (02/22/2017), 10192016A (02/28/2017), 10242016B (02/28/2017).", "product_quantity": "920 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2016-11-17", "center_classification_date": "2017-01-04", "report_date": "2017-01-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "NAD+", "matched_compound_slugs": "nad-plus", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0333-2017", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Wells Pharmacy Network LLC", "state": "FL", "product_description": "Nicotinamide Adenine Dinucleotide (NADH) - Lyophilized (P.F.) 100 mg Injectable, Compounded by Wells Pharmacy, Ocala, FL", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 03302016@13, 06302016@95, 08082016@58.", "product_quantity": "Unknown", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2016-09-21", "center_classification_date": "2017-01-04", "report_date": "2017-01-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0361-2017", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Wells Pharmacy Network LLC", "state": "FL", "product_description": "Glutathione 200 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 07252016@46, 08112016@19.", "product_quantity": "148 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2016-09-21", "center_classification_date": "2017-01-04", "report_date": "2017-01-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0386-2017", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Wells Pharmacy Network LLC", "state": "FL", "product_description": "Sermorelin Acetate 15 mg Injectable Kit., Compounded by Wells Pharmacy, Ocala, FL", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05182016@173, 07052016@148, 09062016@114. Known vial lot code: 04252016@165, 06102016@56, 08262016@42.", "product_quantity": "568 kits (number of vials per kit vary by prescription)", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2016-09-21", "center_classification_date": "2017-01-04", "report_date": "2017-01-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0387-2017", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Wells Pharmacy Network LLC", "state": "FL", "product_description": "Sermorelin Acetate 28 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05182016@51, 05262016@146, 06212016@76, 08052016@74. Known vial lot code: 04252016@163, 05042016@87, 07192016@31.", "product_quantity": "330 kits (number of vials per kit vary by prescription)", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2016-09-21", "center_classification_date": "2017-01-04", "report_date": "2017-01-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0388-2017", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Wells Pharmacy Network LLC", "state": "FL", "product_description": "Sermorelin Acetate 9 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04212016@55, 06222016@106. Known vial lot code: 04142016@31, 06012016@50.", "product_quantity": "629 kits (number of vials per kit vary by prescription)", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2016-09-21", "center_classification_date": "2017-01-04", "report_date": "2017-01-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0389-2017", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Wells Pharmacy Network LLC", "state": "FL", "product_description": "Sermorelin Acetate/GHRP (2) & (6) 9 mg/3.15 mg/3.15 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05122016@180, 06132016@155, 06232016@147, 07062016@156, 07272016@68, 08232016@24, 09062016@74. Known vial lot code: 04212016@110, 052412016@76, 05312016@40, 06102016@52, 07152016@56, 08192016@20, 08102016@56.", "product_quantity": "3,089 kits (number of vials per kit vary by prescription)", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2016-09-21", "center_classification_date": "2017-01-04", "report_date": "2017-01-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0390-2017", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Wells Pharmacy Network LLC", "state": "FL", "product_description": "Sermorelin Acetate/GHRP (2) & (6) 9 mg/9 mg/9 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04072016@19, 05272016@55, 06102016@62, 09062016@75. Known vial lot code: 03302016@11, 050412016@98, 05172016@10, 08252016@18.", "product_quantity": "1,319 kits (number of vials per kit vary by prescription)", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2016-09-21", "center_classification_date": "2017-01-04", "report_date": "2017-01-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0391-2017", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Wells Pharmacy Network LLC", "state": "FL", "product_description": "Sermorelin Acetate/GHRP (2) 9 mg/9 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05182016@215, 09062016@92. Known vial lot code: 04252016@158, 082612016@45.", "product_quantity": "158 kits (number of vials per kit vary by prescription)", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2016-09-21", "center_classification_date": "2017-01-04", "report_date": "2017-01-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0392-2017", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Wells Pharmacy Network LLC", "state": "FL", "product_description": "Sermorelin Acetate/GHRP (2) Kit 6 mg/4.5 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04062016@170, 05272016@67, 09132016@98. Known vial lot code: 03302016@12, 050412016@84, 08222016@27.", "product_quantity": "176 kits (number of vials per kit vary by prescription)", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2016-09-21", "center_classification_date": "2017-01-04", "report_date": "2017-01-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0393-2017", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Wells Pharmacy Network LLC", "state": "FL", "product_description": "Sermorelin Acetate/GHRP (2)/Theanine 15 mg/5.4 mg/75 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05162016@37, 06172016@161, 06242016@135, 08112016@121. Known vial lot code: 04202016@8, 05252016@33, 05312016@47, 08042016@39.", "product_quantity": "1,255 kits (number of vials per kit vary by prescription)", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2016-09-21", "center_classification_date": "2017-01-04", "report_date": "2017-01-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0394-2017", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Wells Pharmacy Network LLC", "state": "FL", "product_description": "Sermorelin Acetate/GHRP (2) 3 mg/4.5 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05272016@100. Known vial lot code: 05042016@94.", "product_quantity": "3 kits (number of vials per kit vary by prescription)", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2016-09-21", "center_classification_date": "2017-01-04", "report_date": "2017-01-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0395-2017", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Wells Pharmacy Network LLC", "state": "FL", "product_description": "Sermorelin Acetate/GHRP (2) 9 mg/3 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala FL", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04152016@149, 05182016@176, 06172016@142, 07272016@83, 08232016@32, 09122016@138. Known vial lot code: 04072016@91, 04262016@27, 05272016@41, 07192016@29, 08192016@18, 09062016@44.", "product_quantity": "2,264 kits (number of vials per kit vary by prescription)", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2016-09-21", "center_classification_date": "2017-01-04", "report_date": "2017-01-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0396-2017", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Wells Pharmacy Network LLC", "state": "FL", "product_description": "Sermorelin Acetate/GHRP (6) 3 mg/3 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05272016@73. Known vial lot code: 05042016@91.", "product_quantity": "106 kits (number of vials per kit vary by prescription)", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2016-09-21", "center_classification_date": "2017-01-04", "report_date": "2017-01-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0397-2017", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Wells Pharmacy Network LLC", "state": "FL", "product_description": "Sermorelin Acetate/GHRP (6) 6 mg/3 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04192016@24, 05172016@229, 06032016@136, 06222016@121, 06222016@148, 09132016@102. Known vial lot code: 03242016@27, 04202016@7, 05162016@141, 06032016@47, 05312016@53, 08222016@54.", "product_quantity": "1,232 kits (number of vials per kit vary by prescription)", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2016-09-21", "center_classification_date": "2017-01-04", "report_date": "2017-01-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0228-2017", "classification_fda": "Class I", "classification": "class-i", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Town and Country Compounding and Consultation Services", "state": "NJ", "product_description": "Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and Country Compounding and Consultation Services, Ridgewood, NJ 074502", "reason_for_recall": "Non-Sterility; microbial contamination identified as Bacillus circulans", "code_info": "lot #07172016@1, exp 1/13/2017", "product_quantity": "12 vials", "distribution_pattern": "MA, NY, NJ & FL; Canada", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2016-08-01", "center_classification_date": "2016-12-22", "report_date": "2016-12-28", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1463-2016", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Talon Compounding Pharmacy", "state": "TX", "product_description": "Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogenated vials, Rx Only, Compounded by Talon Compounding Pharmacy, San Antonio, TX 78247", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot numbers: 01082016:58 01082016:58 01082016:58 01082016:58 01082016:58 01082016:58 01082016:58 01082016:58 01202016:78 01202016:78 01202016:78 01202016:78 01202016:78 01202016:78 01202016:78 01202016:78 01202016:78 01202016:78 01202016:78 01202016:78 01202016:78 02012016:61 02012016:61 02012016:61 02012016:61 02012016:61 02012016:61 02012016:61 02012016:61 02012016:61 02012016:61 02012016:61 02012016:61 02012016:61 02012016:61 02012016:61 02012016:61 02052016:52 02012016:61 02052016:52 02052016:52 02052016:52 02052016:52 02052016:52 02052016:52 02052016:52 02052016:52 02052016:52 02052016:52 02052016:52 02052016:52 02052016:52 02052016:52 02052016:52 02052016:52 03042016:55 03042016:55 03042016:55 03042016:55 03042016:55 03042016:55 03042016:55 03042016:55 03042016:55 03042016:55 03102016:77 03042016:55 03092016:75 03092016:75 03092016:75 03092016:75 03092016:75 03092016:75 03092016:75 03092016:75 03212016:63 03092016:75 03092016:75 03092016:75 03092016:75 03092016:75 03092016:75 03092016:75 03092016:75 03092016:75 03222016:00 03222016:00 03222016:00 03222016:00 03222016:00 03292016:85 03292016:85 03222016:00 03292016:85 03292016:85 03222016:00 03222016:00 03292016:85 03222016:00 03222016:00 03222016:00 03222016:00 03222016:00 03302016:74 03222016:00 04012016:65 03302016:74 04012016:65 04012016:65 04012016:65 04012016:65 04012016:65 03302016:74 03302016:74 04012016:65 03302016:74 04012016:65 04012016:65 04012016:65 03302016:74 04012016:65 03302016:74 04012016:65 04012016:65 04072016:14 04012016:65 04012016:65 04012016:65 04012016:65 04112016:60 04062016:57 04062016:57 04062016:57 04062016:57 03302016:74 04062016:57 03302016:74 04042016:09 04062016:57 04062016:57 04042016:09 04042016:09 04062016:57 04012016:65 04042016:09 04042016:09 04012016:65 04062016:57 04062016:57 04062016:57 04062016:57 04012016:65 04012016:65 04012016:65 04062016:57 04062016:57 04062016:57 04062016:57 04062016:57 04132016:97 04042016:09 04132016:97 04132016:97 04132016:97 04132016:97 04132016:97 04132016:97 04132016:97 04042016:09 04132016:97 04042016:09 04042016:09 04132016:97 04132016:97 04132016:97 04132016:97 04132016:97 04132016:97 04132016:97 04042016:09 04132016:97 05032016:78 05032016:78 04292016:08 04292016:08 04292016:08 04292016:08 04292016:08 04292016:08 04292016:08 05032016:78 05032016:78 05032016:78 05032016:78 04292016:08 04292016:08 04292016:08 04292016:08 04292016:08 04292016:08 05032016:78 05032016:78 05032016:78 05032016:78 05032016:78 04292016:08 04292016:08 04292016:08 04292016:08 05112016:46 04292016:08 05112016:86 05112016:86 05112016:86 05122016:46 05112016:86 05112016:46 05112016:86 05112016:86 05112016:86 05112016:86 05112016:86 05112016:86 05112016:86 05112016:86 05112016:86 05112016:46 05112016:86 05112016:46 05112016:46 05112016:86 05112016:86 05112016:86 05112016:86 05112016:46 05112016:86 05192016:92 05192016:92 05192016:92 05192016:92 05242016:09 05112016:46 05192016:92 05192016:92 05192016:92 05192016:92 05112016:46 05112016:46 05192016:92 05192016:92 05192016:92 05192016:92 05192016:92 05262016:96 05262016:96 05192016:92 05262016:96 05192016:92 05192016:92 05262016:96 05192016:92 05192016:92 05192016:92 05192016:92 05192016:92 06062016:06 06062016:06 06062016:06 06062016:06 06062016:06 06062016:06 06062016:06 05262016:96 05262016:96 06062016:06 06062016:06 06062016:06 05262016:96 05262016:96 06062016:06 06062016:06 06062016:06 06062016:06 06062016:06 06062016:06 06062016:06 06092016:66 06062016:06 06092016:66 06092016:66 05262016:96 06092016:66 06092016:66 06092016:66 06092016:66 06092016:66 06092016:66 05262016:96 05262016:96 06092016:66 06092016:66 06092016:66 06092016:66 06152016:07 06152016:07 06152016:66 06132016:81 06132016:81 06132016:81 06132016:81 06152016:07 06152016:07 06152016:07 06132016:81 06132016:81 06152016:07 06152016:66 06152016:66 06152016:07 06132016:81 06152016:07 06152016:66 06152016:07 06152016:66 06152016:07 06222016:22 06222016:22 06132016:81 06132016:81 06152016:07 06152016:66 06152016:66 06132016:81 06132016:81 06152016:66 06152016:66 06152016:66 06152016:66 06152016:66 06152016:66 06152016:66 06272016:42 06152016:66 06152016:66 06272016:16 06132016:81 06152016:66 06272016:16 06272016:16 06272016:02 06272016:16 06272016:02 06272016:16 06272016:16 06272016:16 06272016:02 06272016:16 06272016:16 06272016:16 06272016:16 06272016:02 06272016:16 06272016:16 06272016:16 07062016:12 07062016:12 07062016:12 07062016:12 07062016:12 07062016:12 06092016:66 07062016:12 07062016:12 07062016:12 07062016:12 07062016:12 07062016:12 07062016:12 06272016:02 06272016:02 07062016:12 07062016:12 06272016:02 07062016:12 07182016:70 07182016:70 07192016:87 07182016:70 07182016:70 07192016:87 07192016:60 07132016:70 07132016:70", "product_quantity": "500 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2016-07-19", "center_classification_date": "2016-08-22", "report_date": "2016-08-31", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1198-2016", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Medaus, Inc.", "state": "AL", "product_description": "L-GLUTATHIONE 100MG/ML (PF), 10 ML Vials, MEDAUS PHARMACY", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "Lot #: 160222-28, BUD: 05/22/16; Lot #: 160302-63, BUD: 05/31/16", "product_quantity": "5000 mL in Vials", "distribution_pattern": "U.S. Nationwide, Japan, and New Zealand.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2016-05-13", "center_classification_date": "2016-07-08", "report_date": "2016-07-20", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0986-2016", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Well Care Compounding Pharmacy", "state": "NV", "product_description": "GLUTATHIONE 100MG/ML, packaged in 10 mL vials, Well Care Compounding Pharmacy Las Vegas, NV 89121", "reason_for_recall": "Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.", "code_info": "Lot #: 02222016:97@38, Exp.05/24/2016; Lot #: 03032016:27@26 , Exp. 06/26/2016; Lot #: 4272016:60@37, Exp. 07/26/2016; Lot #: 01132016:18@44, Exp. 02/03/2016; Lot #: 01132016:74 @17, Exp. 03/04/2016; Lot #: 01132016:90@9, Exp. 03/04/2016; Lot #: 02222016:34@23, Exp. 04/03/2016; Lot #: 04282016:79@45, Exp. 06/27/2016", "product_quantity": "869 Units (Total All Products)", "distribution_pattern": "NV", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2016-05-17", "center_classification_date": "2016-06-09", "report_date": "2016-06-15", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0987-2016", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Well Care Compounding Pharmacy", "state": "NV", "product_description": "GLUTATHIONE 200MG/ML, packaged in 5mL vials, Well Care Compounding Pharmacy Las Vegas, NV 89121", "reason_for_recall": "Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.", "code_info": "Lot #: 02232016: 64@43, Exp. 05/24/2016; Lot #: 03142016: 70@16,Exp. 06/14/2016; Lot #: 04182016:17@15, Exp.07/17/2016; Lot #: 04182016:64@12, Exp. 07/18/2016.", "product_quantity": "869 Units (Total All Products)", "distribution_pattern": "NV", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2016-05-17", "center_classification_date": "2016-06-09", "report_date": "2016-06-15", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0407-2016", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Western Drug", "state": "AZ", "product_description": "Glutathione 200 mg/mL SVN Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "all lots", "product_quantity": "1 container", "distribution_pattern": "Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2015-10-19", "center_classification_date": "2015-12-01", "report_date": "2015-12-09", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0408-2016", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Western Drug", "state": "AZ", "product_description": "Glutathione 300 mg/1.5 mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "all lots", "product_quantity": "1 container", "distribution_pattern": "Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2015-10-19", "center_classification_date": "2015-12-01", "report_date": "2015-12-09", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0450-2016", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Western Drug", "state": "AZ", "product_description": "Sermorelin Injection 10mg/10mL,10mg/mL, 20mg/10mL, 9mg/9mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "all lots", "product_quantity": "45 containers", "distribution_pattern": "Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2015-10-19", "center_classification_date": "2015-12-01", "report_date": "2015-12-09", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0364-2016", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Downing Labs, LLC", "state": "TX", "product_description": "Sermorelin/GHRP-6/GHRP-2 Injection 3MG/3MG/3MG, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lots", "product_quantity": "287 vials", "distribution_pattern": "Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2015-10-16", "center_classification_date": "2015-11-18", "report_date": "2015-11-25", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0370-2016", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Downing Labs, LLC", "state": "TX", "product_description": "L-Glutathione Injection, 200mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lots", "product_quantity": "467 vials", "distribution_pattern": "Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2015-10-16", "center_classification_date": "2015-11-18", "report_date": "2015-11-25", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-324-2016", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Kalman Health & Wellness, Inc. dba Essential Wellness Pharma", "state": "IL", "product_description": "Sermorelin 9 mg/10 mL SUB-Q* Injection, packaged in a) 3 mL, b) 5 mL, c) 6 mL, or d) 9 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.", "reason_for_recall": "Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.", "code_info": "Lot #: 080515, Exp 09/05/2015; 080715, Exp 09/07/2015; 081115, Exp 09/11/2015; and 081415, Exp. Date 09/14/2015", "product_quantity": "7 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2015-09-03", "center_classification_date": "2015-11-17", "report_date": "2015-11-25", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-325-2016", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Kalman Health & Wellness, Inc. dba Essential Wellness Pharma", "state": "IL", "product_description": "Sermorelin 1000 mcg/mL SUB-Q* Injection, packaged in a) 3 mL, b) 6mL, c) 7.5ml, d) 9 mL or e) 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.", "reason_for_recall": "Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.", "code_info": "Lot #: 080415, Exp 09/04/2015; 080515, Exp 09/05/2015; 080615, Exp 09/06/2015; 080715, Exp 09/07/2015; 081015, Exp 09/10/2015; 081115, Exp 09/11/2015; 081215, Exp 09/12/2015; 081315, Exp 09/13/2015; 081415, Exp 09/13/2015; 081515, Exp 09/15/2015; 453-081715, Exp 09/17/2015; 453-081815, Exp 09/18/2015; and 453-081915, Exp 09/19/2015", "product_quantity": "64 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2015-09-03", "center_classification_date": "2015-11-17", "report_date": "2015-11-25", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-326-2016", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Kalman Health & Wellness, Inc. dba Essential Wellness Pharma", "state": "IL", "product_description": "sermorelin 1000 mcg/mL / LIDO 0.2% Injection, 6 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.", "reason_for_recall": "Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.", "code_info": "Lot #: 080415, Exp 09/04/2015", "product_quantity": "2 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2015-09-03", "center_classification_date": "2015-11-17", "report_date": "2015-11-25", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0092-2016", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "JD & SN Inc., dba Moses Lake Professional Pharmacy", "state": "WA", "product_description": "GLUTATHIONE MDV, Injectable Solution, 200 mg/mL, syringe sizes: 60 mL, 90 mL; 100 mL; and 150 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314", "reason_for_recall": "Lack of Assurance of Sterility; all sterile human compounded drugs within expiry", "code_info": "t12012014@6, t09182014@28, t09162014@31, t09162014@22, t08292014@6, t08122014@26, t07222014@15, t05262015@13, t01192015@11, t05082015@4, t04202015@13", "product_quantity": "1 (60mL) syringe, 3 (90mL) syringe, 5 (100mL) syringe, 1 (150mL) syringe", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2015-07-24", "center_classification_date": "2015-10-27", "report_date": "2015-11-04", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0093-2016", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "JD & SN Inc., dba Moses Lake Professional Pharmacy", "state": "WA", "product_description": "GLUTATHIONE (L), Injectable Solution, 75 mg/mL, 64 mL syringe , Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314", "reason_for_recall": "Lack of Assurance of Sterility; all sterile human compounded drugs within expiry", "code_info": "t03192015@31, t04272015@5", "product_quantity": "2 syringes", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2015-07-24", "center_classification_date": "2015-10-27", "report_date": "2015-11-04", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0120-2016", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "JD & SN Inc., dba Moses Lake Professional Pharmacy", "state": "WA", "product_description": "SERMORELIN/GHRP-6/GHRP-2, Injectable Solution, 4.5/5.4/5.4MG/9ML, 9mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314.", "reason_for_recall": "Lack of Assurance of Sterility; all sterile human compounded drugs within expiry", "code_info": "t04162015@33, t05112015@19, t05282015@2, t07062015@7, t07092015@43.", "product_quantity": "5 syringes", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2015-07-24", "center_classification_date": "2015-10-27", "report_date": "2015-11-04", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0121-2016", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "JD & SN Inc., dba Moses Lake Professional Pharmacy", "state": "WA", "product_description": "SERMORELIN/GHRP-6/GHRP-2, Injectable Solution, 9/5.4/5.4MG/9ML, 9mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314", "reason_for_recall": "Lack of Assurance of Sterility; all sterile human compounded drugs within expiry", "code_info": "t10062014@19, t09152014@13, t08262014@1, t08072014@20, t05282015@28, t03062015@14, t02162015@26, 12222014@3, 11262014@6, 11172014@4, 11052014@3, 10272014@7, 10222014@23, 10202014@20, 10152014@5, 10012014@17, 09102014@3, 08182014@9, 07222014@31, 06292015@10, 06232014@3, 06222015@6, 05132015@7, 05062015@7, 05042015@4, 04272015@8, 04222015@6, 03302015@11, 03252015@9, 02202015@24, 01232015@20, 01192015@1, 01052015@8.", "product_quantity": "165 syringes", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2015-07-24", "center_classification_date": "2015-10-27", "report_date": "2015-11-04", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0122-2016", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "JD & SN Inc., dba Moses Lake Professional Pharmacy", "state": "WA", "product_description": "SERMORELIN/GHRP-6/GHRP-2, Injectable Solution, 9/9/9MG/9ML, 9 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314", "reason_for_recall": "Lack of Assurance of Sterility; all sterile human compounded drugs within expiry", "code_info": "t12052014@8, t11192014@26, t11032014@24, t10142014@27, t09172014@2, t08252014@30, t07302014@12, t07092014@15, t06022015@10, t04302015@22, t03312015@18, t03172015@28, t03092015@38, t02102015@21, 10222014@8, 10012014@16, 05132015@5, 02172015@7, 01052015@9.", "product_quantity": "41 syringes", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2015-07-24", "center_classification_date": "2015-10-27", "report_date": "2015-11-04", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-0006-2016", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Diabetes Corporation of America dba DCA Pharmacy", "state": "TN", "product_description": "Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN 37064-5527", "reason_for_recall": "Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being compounded in an area appropriate for lyophilization which may lead to a lack of sterility assurance.", "code_info": "Lot #: 101614, Exp 4/30/2015", "product_quantity": "129 vials", "distribution_pattern": "KY, OH, TN", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2015-09-23", "center_classification_date": "2015-10-05", "report_date": "2015-10-14", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1443-2015", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "The Compounding Pharmacy of America", "state": "TN", "product_description": "Ascorbic Acid 1.25% Glutathione 1.25% DMSO 6.25% Ophthalmic Solution, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN", "reason_for_recall": "Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility", "code_info": "All lots distributed between November 2014 and May 2015; 03032015@24, 6/1/2015; 03312015@79, 6/29/2015", "product_quantity": "13 mL total volume", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2015-06-02", "center_classification_date": "2015-09-15", "report_date": "2015-09-23", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1503-2015", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "The Compounding Pharmacy of America", "state": "TN", "product_description": "Glutathione 200 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN", "reason_for_recall": "Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility", "code_info": "All lots distributed between November 2014 and May 2015; 03162015@78, 6/14/2015; 03262015@42, 6/24/2015; 04202015@82, 7/19/2015; 04222015@79, 7/21/2015; 05042015@49, 8/2/2015; 04222015@57, 7/21/2015; 04272015@19, 7/26/2015", "product_quantity": "559 ml total volume", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2015-06-02", "center_classification_date": "2015-09-15", "report_date": "2015-09-23", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1629-2015", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "The Compounding Pharmacy of America", "state": "TN", "product_description": "Sermorelin 1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN", "reason_for_recall": "Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility", "code_info": "All lots distributed between November 2014 and May 2015; 04092015@84, 6/8/2015; 04062015@55, 6/5/2015; 04222015@104, 6/21/2015; 04292015@47, 6/28/2015", "product_quantity": "77 ml", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2015-06-02", "center_classification_date": "2015-09-15", "report_date": "2015-09-23", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1630-2015", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "The Compounding Pharmacy of America", "state": "TN", "product_description": "Sermorelin/GHRP2 1000/1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN", "reason_for_recall": "Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility", "code_info": "All lots distributed between November 2014 and May 2015; 04092015@9, 6/8/2015; 04152015@59, 6/14/2015; 04042015@26, 6/6/2015; 04132015@36, 6/12/2015", "product_quantity": "43 ml total volume", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2015-06-02", "center_classification_date": "2015-09-15", "report_date": "2015-09-23", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1631-2015", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "The Compounding Pharmacy of America", "state": "TN", "product_description": "Sermorelin/GHRP6 1000/1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN", "reason_for_recall": "Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility", "code_info": "All lots distributed between November 2014 and May 2015; 05072015@31, 7/6/2015; 03232015@11, 5/22/2015; 03302015@44, 5/29/2015; 03272015@16, 5/26/2015; 04222015@81, 6/1/2015; 04032015@15, 6/2/2015; 04142015@9, 6/13/2015; 04232015@11, 6/22/2015; 04272015@42, 6/26/2015; 04292015@86, 6/28/2015", "product_quantity": "185 ml total volume", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2015-06-02", "center_classification_date": "2015-09-15", "report_date": "2015-09-23", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1632-2015", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "The Compounding Pharmacy of America", "state": "TN", "product_description": "Sermorelin 1000mcg/GHRP6 1000/GHRP2 1000 ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN", "reason_for_recall": "Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility", "code_info": "All lots distributed between November 2014 and May 2015; 03242015@91, 5/23/2015; 04012015@50, 5/31/2015; 04242015, 6/23/2015", "product_quantity": "41 ml", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2015-06-02", "center_classification_date": "2015-09-15", "report_date": "2015-09-23", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1633-2015", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "The Compounding Pharmacy of America", "state": "TN", "product_description": "Sermorelin 300 mcg/ml + GHRP-2 300 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN", "reason_for_recall": "Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility", "code_info": "All lots distributed between November 2014 and May 2015; 04012015@76, 5/31/2015, 04062015@11, 6/5/2015", "product_quantity": "32 ml", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2015-06-02", "center_classification_date": "2015-09-15", "report_date": "2015-09-23", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1121-2015", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Montana Compounding Pharmacy", "state": "MT", "product_description": "Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT.", "reason_for_recall": "Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection", "code_info": "Lot 04102015:70@12; expiry date 5/28/2015.", "product_quantity": "20/4 mL vials", "distribution_pattern": "MT and ND", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2015-05-15", "center_classification_date": "2015-06-09", "report_date": "2015-06-17", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1122-2015", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Montana Compounding Pharmacy", "state": "MT", "product_description": "Glutathione INHALATION (PF), NASAL solution, 100 mg/mL, 3 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT", "reason_for_recall": "Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection", "code_info": "Lot 04102015:36@11, expiry date: 5/29/2015", "product_quantity": "10/3 mL vials", "distribution_pattern": "MT and ND", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2015-05-15", "center_classification_date": "2015-06-09", "report_date": "2015-06-17", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1096-2015", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Advanced Physician Solutions, Inc.", "state": "CA", "product_description": "GLUTATHIONE 200MG/ML (STERILE WATER) (30ML, 50ML VIAL) INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605", "reason_for_recall": "Lack of Assurance of Sterility", "code_info": "All lots", "product_quantity": null, "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2015-05-18", "center_classification_date": "2015-05-28", "report_date": "2015-06-03", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0335-2015", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Right Value Drug Stores, Inc.", "state": "TX", "product_description": "Glutathione 200 mg/mL Injectable, packaged in a) 5 mL MDV (multiple dose vials), b) 30 mL MDV (multiple dose vials), and c) 100 mL MDV (multiple dose vials), Rx only, Carie Boyd's Prescription Shop, 122 Grapevine Highway, Hurst, TX 76054, (817) 282-9376.", "reason_for_recall": "Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial.", "code_info": "Lot #: 11142014@5, 10142014@17, 11032014@13, 08262014@6, 09162014@6, 06272014@12, 08052014@5, 07222014@18, 07222014@3, 06262014@11, 06182014@3", "product_quantity": "a) 26 vials, b) 15 vials, c) 16 vials", "distribution_pattern": "KS, MO, and TX.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2014-12-12", "center_classification_date": "2015-01-08", "report_date": "2015-01-14", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0306-2015", "classification_fda": "Class I", "classification": "class-i", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Pharmacy Creations", "state": "NJ", "product_description": "Glutathione 100mg/mL Sterile Injection, 30 mL Multi Dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.", "reason_for_recall": "Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.", "code_info": "Lot #: 05122014@4, Exp 09/09/2014", "product_quantity": "12 vials", "distribution_pattern": "Directly to patients and physicians in FL, NJ, NY, and Puerto Rico", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2014-09-05", "center_classification_date": "2014-12-19", "report_date": "2014-12-31", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0195-2015", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Oregon Compounding Centers, Inc. dba Creative Compounds", "state": "OR", "product_description": "GLUTATHIONE with preservative, 100mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070", "reason_for_recall": "Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.", "code_info": "Lot #: 20140721@25/00, discard date: 11/18/2014; Lot #: 20140902@47, discard date: 12/31/2014.", "product_quantity": "2200 mL", "distribution_pattern": "Oregon, Washington", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2014-10-06", "center_classification_date": "2014-10-31", "report_date": "2014-11-12", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-0196-2015", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Oregon Compounding Centers, Inc. dba Creative Compounds", "state": "OR", "product_description": "GLUTATHIONE, 100 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070", "reason_for_recall": "Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.", "code_info": "Lot #: 20140718@4, discard date: 10/16/2014", "product_quantity": "900 mL", "distribution_pattern": "Oregon, Washington", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2014-10-06", "center_classification_date": "2014-10-31", "report_date": "2014-11-12", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1533-2014", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Medical Supply Liquidators Llc", "state": "IA", "product_description": "Glutathione Injection USP, 200 mg/ml, packaged in 30 ml vials, Sterile, For IM of Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.", "reason_for_recall": "Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer", "code_info": "All lot numbers and exp dates", "product_quantity": "N/A", "distribution_pattern": "Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2014-06-25", "center_classification_date": "2014-08-06", "report_date": "2014-08-13", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1317-2014", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Completed", "status": "completed", "recalling_firm": "Flawless Beauty LLC", "state": "NJ", "product_description": "Tatiomax (reduced glutathione/hydrolyzed collagen) powder for injection vials, 1200 mg/200 mg, 10-count vials per box, Manufactured by: Sujie Pharmaceutical Ltd., Tokyo, Japan, UPC 4973430081576", "reason_for_recall": "Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.", "code_info": "Lot #: UB302, Exp 05/12/15", "product_quantity": "unknown", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2014-04-29", "center_classification_date": "2014-05-13", "report_date": "2014-05-21", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1318-2014", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Completed", "status": "completed", "recalling_firm": "Flawless Beauty LLC", "state": "NJ", "product_description": "Saluta (reduced glutathione) Powder for Injection, 600 mg/vial, packaged in 10 vials per box, Exclusively Distributed by: QAF Pharmaceuticals Inc. Philippines, Unit Unit 202 ECG Building, Multinational Avenue, Multinational Village, Parahaque City, Metro Manila Philippines; Manufactured by: Shandong Luye Pharmaceutical Co. Ltd, Yantai Shandong, PRC la Luye Pharma Subsidiary, UPC 6920425209014", "reason_for_recall": "Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.", "code_info": "Lot #: 201302275, Exp 01/20/15; 201308384, Exp 10/19/2015", "product_quantity": "unknown", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2014-04-29", "center_classification_date": "2014-05-13", "report_date": "2014-05-21", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1319-2014", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Completed", "status": "completed", "recalling_firm": "Flawless Beauty LLC", "state": "NJ", "product_description": "Relumins Advanced Glutathione (lyophilized glutathione/vitamin C) injectable solution, 1500 mg/500 mg, packaged in 8-count vials, 8-count 5 mL vitamin C (ascorbic acid) solution diluent ampoules, and 30-count Advanced Glutathione Boosters capsules per box, Relumins Labs, 183 Locust Avenue, West Long Branch, NJ 07764, UPC 700175760302", "reason_for_recall": "Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used parenterally for drug claims.", "code_info": "Lot #: 130616, Exp 06/16", "product_quantity": "unknown", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2014-04-29", "center_classification_date": "2014-05-13", "report_date": "2014-05-21", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1116-2014", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Natures Pharmacy & Compounding Center", "state": "NC", "product_description": "L-Glutathione inhalation", "reason_for_recall": "Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.", "code_info": "All lot numbers within expiry.", "product_quantity": null, "distribution_pattern": "NC", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2013-11-01", "center_classification_date": "2014-03-04", "report_date": "2014-03-12", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1117-2014", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Natures Pharmacy & Compounding Center", "state": "NC", "product_description": "Glutathione 6%/ascorbic 1%/DMSO 6.25%", "reason_for_recall": "Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.", "code_info": "All lot numbers within expiry.", "product_quantity": null, "distribution_pattern": "NC", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2013-11-01", "center_classification_date": "2014-03-04", "report_date": "2014-03-12", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1118-2014", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Natures Pharmacy & Compounding Center", "state": "NC", "product_description": "Glutathione 1.25%/Ascorbic 1.25%/DMSO 6.25%", "reason_for_recall": "Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.", "code_info": "All lot numbers within expiry.", "product_quantity": null, "distribution_pattern": "NC", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2013-11-01", "center_classification_date": "2014-03-04", "report_date": "2014-03-12", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1119-2014", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Natures Pharmacy & Compounding Center", "state": "NC", "product_description": "Glutathione Inhalation 200mg/5ml", "reason_for_recall": "Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.", "code_info": "All lot numbers within expiry.", "product_quantity": null, "distribution_pattern": "NC", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2013-11-01", "center_classification_date": "2014-03-04", "report_date": "2014-03-12", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1052-2014", "classification_fda": "Class I", "classification": "class-i", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "NuVision Pharmacy, Inc.", "state": "TX", "product_description": "Sermorelin/GHRP-6, 3 mg/3 mg, 5 mL vial, Stock # 21740, Compounded by NuVision Pharmacy, Dallas, TX 75244", "reason_for_recall": "Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.", "code_info": "Lot #:N10172012@11, Exp 10/17/2013", "product_quantity": "122 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2013-04-15", "center_classification_date": "2014-01-30", "report_date": "2014-02-05", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-423-2014", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Specialty Medicine Compounding Pharmacy", "state": "MI", "product_description": "Glutathione PF, 60 mg/mL inhalation, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178", "reason_for_recall": "Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.", "code_info": "All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 10112013@1", "product_quantity": "126 mL", "distribution_pattern": "Hospitals, clinics, physicians, and patients in the Michigan area only.", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2013-10-19", "center_classification_date": "2014-01-10", "report_date": "2014-01-22", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-097-2014", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Main Street Family Pharmacy, LLC", "state": "TN", "product_description": "Glutathione \"Reduced\" 200mg/ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200", "reason_for_recall": "The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.", "code_info": "all codes distributed prior to and including 05/23/2013", "product_quantity": "19 units", "distribution_pattern": "nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2013-05-28", "center_classification_date": "2013-12-03", "report_date": "2013-12-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-098-2014", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Main Street Family Pharmacy, LLC", "state": "TN", "product_description": "Glutathione 150mg/ml 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200", "reason_for_recall": "The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.", "code_info": "all codes distributed prior to and including 05/23/2013", "product_quantity": "1 unit", "distribution_pattern": "nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2013-05-28", "center_classification_date": "2013-12-03", "report_date": "2013-12-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-158-2014", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Main Street Family Pharmacy, LLC", "state": "TN", "product_description": "L-glutathione 200mg/ml 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200", "reason_for_recall": "The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.", "code_info": "all codes distributed prior to and including 05/23/2013", "product_quantity": "3 units", "distribution_pattern": "nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2013-05-28", "center_classification_date": "2013-12-03", "report_date": "2013-12-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-262-2014", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Main Street Family Pharmacy, LLC", "state": "TN", "product_description": "Sermorelin 15mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200", "reason_for_recall": "The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.", "code_info": "all codes distributed prior to and including 05/23/2013", "product_quantity": "12 units", "distribution_pattern": "nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2013-05-28", "center_classification_date": "2013-12-03", "report_date": "2013-12-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-263-2014", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Main Street Family Pharmacy, LLC", "state": "TN", "product_description": "Sermorelin 6mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200", "reason_for_recall": "The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.", "code_info": "all codes distributed prior to and including 05/23/2013", "product_quantity": "706 units", "distribution_pattern": "nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2013-05-28", "center_classification_date": "2013-12-03", "report_date": "2013-12-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-264-2014", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Main Street Family Pharmacy, LLC", "state": "TN", "product_description": "Sermorelin GHRP 9mg/3mg/3mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200", "reason_for_recall": "The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.", "code_info": "all codes distributed prior to and including 05/23/2013", "product_quantity": "51 units", "distribution_pattern": "nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2013-05-28", "center_classification_date": "2013-12-03", "report_date": "2013-12-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-265-2014", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Main Street Family Pharmacy, LLC", "state": "TN", "product_description": "Sermorelin 3mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200", "reason_for_recall": "The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.", "code_info": "all codes distributed prior to and including 05/23/2013", "product_quantity": "71 units", "distribution_pattern": "nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2013-05-28", "center_classification_date": "2013-12-03", "report_date": "2013-12-11", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1051-2013", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Medaus, Inc.", "state": "AL", "product_description": "L-Glutathione 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183", "reason_for_recall": "Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.", "code_info": "LOT # 130617-10, Exp 12/14/2013", "product_quantity": "6130 mL", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2013-08-23", "center_classification_date": "2013-09-13", "report_date": "2013-09-25", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1019-2013", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Creative Compounds", "state": "OR", "product_description": "Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative Compounds, Wilsonville, OR 97070.", "reason_for_recall": "Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or potential bacterial contamination and it was reported as passing by a contract laboratory.", "code_info": "Lot #: 20130715@12, Exp10/13/2013", "product_quantity": "16 vials", "distribution_pattern": "Oregon and Washington", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2013-08-23", "center_classification_date": "2013-09-10", "report_date": "2013-09-18", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1034-2013", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Wellness Pharmacy, Inc.", "state": "AL", "product_description": "RL Glutathione 100 mg/mL, SDV PF,a) 1 mL, b) 2 mL, c) 3 mL, and d) 4 mL, WELLNESS PHARMACY, 1-800-227-2627", "reason_for_recall": "Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.", "code_info": "Lot# 130710@27, Use By: 1/6/2014", "product_quantity": "34 Vials", "distribution_pattern": "Nationwide and Puerto Rico", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2013-08-23", "center_classification_date": "2013-09-12", "report_date": "2013-09-18", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-961-2013", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Beacon Hill Medical Pharmacy, P.C.", "state": "MI", "product_description": "GLUTATHIONE 200 MG/ML (PF) INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI", "reason_for_recall": "Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance", "code_info": "03192013@30, 02202013@6, 04042013@2, 04302013@20, 04252013@19 06202013@35, 06212013@17", "product_quantity": "N/A", "distribution_pattern": "USA nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2013-07-26", "center_classification_date": "2013-09-10", "report_date": "2013-09-18", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-962-2013", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Beacon Hill Medical Pharmacy, P.C.", "state": "MI", "product_description": "GLUTATHIONE/LIDO 100MG/2%/ML (PF) INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI", "reason_for_recall": "Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance", "code_info": "03202013@28, 04022013@23, 04042013@3, 06172013@25", "product_quantity": "N/A", "distribution_pattern": "USA nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2013-07-26", "center_classification_date": "2013-09-10", "report_date": "2013-09-18", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-963-2013", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Beacon Hill Medical Pharmacy, P.C.", "state": "MI", "product_description": "GLUTATHIONE/METHYL/LIDO 100/25/20 MG/ML INJ SOLN and GLUTATHIONE/METHYL/LIDO 100/25/20MG/ML (PF) INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI", "reason_for_recall": "Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance", "code_info": "06132013@6 04242013@33", "product_quantity": "N/A", "distribution_pattern": "USA nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2013-07-26", "center_classification_date": "2013-09-10", "report_date": "2013-09-18", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-997-2013", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Beacon Hill Medical Pharmacy, P.C.", "state": "MI", "product_description": "SERMORELIN ACETATE 10 MG INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI", "reason_for_recall": "Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance", "code_info": "03182013@6, 03282013@26,01142013@2, 01182013@2, 01172013@15, 02192013@3, 03062013@8, 04102013@3, 04262013@11, 05142013@35, 05212013@20, 5212013@17, 05242013@6, 06082013@3, 06072013@10, 06182013@27, 06292013@1, 07132013@2, 07232013@3, 03182013@14", "product_quantity": "N/A", "distribution_pattern": "USA nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2013-07-26", "center_classification_date": "2013-09-10", "report_date": "2013-09-18", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-736-2013", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Lowlite Investments, Inc. D/B/A Olympia Pharmacy", "state": "FL", "product_description": "Glutathione 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL", "reason_for_recall": "Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes", "code_info": "C5110 Exp 9/11/13", "product_quantity": "1", "distribution_pattern": "Nationwide and PR", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2013-05-29", "center_classification_date": "2013-07-11", "report_date": "2013-07-17", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-779-2013", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Ongoing", "status": "ongoing", "recalling_firm": "Lowlite Investments, Inc. D/B/A Olympia Pharmacy", "state": "FL", "product_description": "Sermorelin/GHRP 3 mg/3 mg vial, compounded by Olympia Pharmacy, Orlando, FL", "reason_for_recall": "Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes", "code_info": "A5811 Exp 11/30/13", "product_quantity": "1", "distribution_pattern": "Nationwide and PR", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2013-05-29", "center_classification_date": "2013-07-11", "report_date": "2013-07-17", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-558-2013", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "THE COMPOUNDING SHOP, INC.", "state": "FL", "product_description": "Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL", "reason_for_recall": "Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes", "code_info": "All Lots", "product_quantity": "7 vials of 50mL each", "distribution_pattern": "Florida, California, Minnesota, and Maine", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2013-05-02", "center_classification_date": "2013-06-04", "report_date": "2013-06-12", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-491-2013", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Nora Apothecary and Alternative Therapies, Inc.", "state": "IN", "product_description": "Glutathione 200mg/ml Inj SDV: 3x50ml 14 day expiration, 1x50ml 21 day expiration", "reason_for_recall": "Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.", "code_info": "All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).", "product_quantity": "2", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2013-04-22", "center_classification_date": "2013-05-29", "report_date": "2013-06-05", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-378-2013", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "FVS Holdings, Inc. dba. Green Valley Drugs", "state": "NV", "product_description": "L-Glutathione Injection, all strengths and all presentations including a) L-Glut-100 mg-30 mL, b) L-Glut-200 mg/30 mL, c) Glutathione 200 mg/ML P.F. 10 mL, d) L-Glutathione-200-30 mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.", "reason_for_recall": "Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.", "code_info": "Lot #: a) L-Glut-100 mg-30 mL: 20130213-D, Exp 5/13/2013; b) L-Glut-200 mg/30 mL: 20130318-J, Exp 6/18/2013; 20130301-C, Exp 6/1/2013 ; d) L-Glutathione-200-30 mL, 30 mL: 20130205-A 5/5/2013", "product_quantity": "430 vials", "distribution_pattern": "Nationwide", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2013-04-10", "center_classification_date": "2013-05-16", "report_date": "2013-05-22", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1508-2012", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Franck's Lab Inc., d.b.a. Franck's Compounding Lab", "state": "FL", "product_description": "DMSO/VITAMIN C/GLUTATHIONE SOLUTION 6.25%/1.25%/1.25% OPHTHALMIC 10 ML, 15 ML, 5 ML (3 DIFFERENT PRODUCTS)", "reason_for_recall": "Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.", "code_info": "Rx #'s: 0393533 0387959 0366146 0395006 0401280 0408662", "product_quantity": "9 units", "distribution_pattern": "Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2012-05-25", "center_classification_date": "2012-08-10", "report_date": "2012-08-22", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Glutathione", "matched_compound_slugs": null, "includes_class_comparator": true, "search_match_count": 1, "recall_number": "D-1529-2012", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Franck's Lab Inc., d.b.a. Franck's Compounding Lab", "state": "FL", "product_description": "GLUTATHIONE INHALATION 30MG/ML SOLUTION 120 ML, 60 ML; GLUTATHIONE P.F. 200MG/ML INJECTABLE\t10 ML, 100 ML, 14 ML, 150 ML, 175 ML, 20 ML, 30 ML, 300 ML, 40 ML, 40 MLS, 50 ML, 58 MLS, 70 ML;\t GLUTATHIONE P.F. 50MG/ML (500MG/10ML) INJECTABLE 100 ML, 150 ML, 20 ML, 40 ML, 60 ML; GLUTATHIONE-FFC 100MG/ML INJECTABLE 20 ML (21 DIFFERENT PRODUCTS)", "reason_for_recall": "Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.", "code_info": "Rx #'s: 0389833 0394741 0392912 0388244 0397159 0399176 0388244 0405177 0409379 0392912 0397159 0377235 0408837 0402247 0388244 0397159 0403342 0404418 0388244 0393276 0393276 0351537 0393276 0351537 0393276 0390499", "product_quantity": "47 units", "distribution_pattern": "Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2012-05-25", "center_classification_date": "2012-08-10", "report_date": "2012-08-22", "fda_matched_an_approved_listing": false }, { "matched_search_terms": "Sermorelin", "matched_compound_slugs": "sermorelin", "includes_class_comparator": false, "search_match_count": 1, "recall_number": "D-1616-2012", "classification_fda": "Class II", "classification": "class-ii", "status_fda": "Terminated", "status": "terminated", "recalling_firm": "Franck's Lab Inc., d.b.a. Franck's Compounding Lab", "state": "FL", "product_description": "SERMORELIN ACETATE, LYOPHILIZED 6MG KIT\t1 KIT \t \t \t \t \t \t2 KIT; \t \t \t SERMORELIN ACETATE, LYOPHILIZED 6MG VIAL\t2 VIAL; \t SERMORELIN ACETATE, LYOPHILIZED 9MG KIT\t1 KIT \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t \t3 KIT \t \t \t6 KIT; SERMORELIN ACETATE, LYOPHILIZED 9MG VIAL\t1 VIAL \t2 VIAL \t \t \t3 VIAL \t \t30 VIAL; SERMORELIN ACETATE/GHRP 2,6 - LYOPHILIZED 9MG/3.15MG/3.15MG KIT\t1 KIT \t \t \t \t \t \t \t \t \t \t \t \t \t3 KIT; SERMORELIN ACETATE/GHRP 2,6 - LYOPHILIZED 9MG/3.15MG/3.15MG VIAL\t1 VIAL \t \t \t \t \t3 VIAL \t \t \t4 VIAL \t7 VIAL (16 DIFFERENT PRODUCTS)", "reason_for_recall": "Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.", "code_info": "Rx #'s: 0386512 0388165 0390153 0392066 0392315 0392317 0384766 0392082 0392094 0379483 0385383 0393729 0397989 0398600 0406470 0407865 0407875 0409041 0410198 0386262 0399600 0386262 0408795 0395274 0395279 0395285 0376062 0389403 0399790 0400511 0400527 0401472 0402407 0402536 0403638 0406466 0406692 0407272 0405789 0394350 0402541 0394350 0392062 0392062", "product_quantity": "63 units", "distribution_pattern": "Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies", "voluntary_or_mandated": "Voluntary: Firm initiated", "recall_initiation_date": "2012-05-21", "center_classification_date": "2012-08-10", "report_date": "2012-08-22", "fda_matched_an_approved_listing": false } ] }