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FDA Drug Recalls

316 recalls, newest first

Class II · Moderate risk Ongoing Apr 19, 2023

Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution Net Contents: 3.785 L (1 Gallon) Container…

Reason Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications

Seatex LLC D-0562-2023

Class II · Moderate risk Ongoing Apr 13, 2023

C-Semaglutide 5mg/mL injection, 0.5mL vials, Rx only, Vital Care Compounder 115 South 40th Ave, Suite A Hattiesburg, MS 39402

Reason Lack of assurance of sterility.

Pharmacy Plus, Inc. dba Vital Care Compounder D-0538-2023

Class II · Moderate risk Ongoing Apr 11, 2023

Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ…

Reason Lack of Assurance of Sterility: Malformed crimped collar seal

Sanofi-Aventis U.S. LLC NDC 0024-5926-05 D-0575-2023

Class II · Moderate risk Ongoing Apr 6, 2023

Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 mL) Drops per bottle, OTC, Distributed by: CVS…

Reason CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.

Pharma Nobis LLC D-0537-2023

Class II · Moderate risk Ongoing Mar 31, 2023

Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) a) 20-count Liquid Filled Capsule…

Reason CGMP deviation: product outside labeled storage temperature requirements.

Family Dollar Stores, Llc. D-0566-2023

Class II · Moderate risk Ongoing Mar 31, 2023

Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles

Reason CGMP deviation: product outside labeled storage temperature requirements.

Family Dollar Stores, Llc. D-0565-2023

Class II · Moderate risk Ongoing Mar 31, 2023

Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count Caplets

Reason CGMP deviation: product outside labeled storage temperature requirements.

Family Dollar Stores, Llc. D-0564-2023

Class II · Moderate risk Ongoing Mar 31, 2023

Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottles, and c)…

Reason CGMP deviation: product outside labeled storage temperature requirements.

Family Dollar Stores, Llc. D-0563-2023

Class II · Moderate risk Ongoing Mar 23, 2023

Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8066-9

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-8066-9 D-0527-2023

Class II · Moderate risk Ongoing Mar 23, 2023

Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC…

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-8153-7 D-0526-2023

Class II · Moderate risk Ongoing Mar 23, 2023

Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b) 60-count bottle (NDC 68788-9868-6); c)…

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-9868-9 D-0525-2023

Class II · Moderate risk Ongoing Mar 23, 2023

Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9); b) 60-count bottle (NDC 68788-9869-6); c)…

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-9869-9 D-0524-2023

Class II · Moderate risk Ongoing Mar 23, 2023

Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC…

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-9429-9 D-0523-2023

Class II · Moderate risk Ongoing Mar 23, 2023

Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC…

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-9747-9 D-0522-2023

Class II · Moderate risk Ongoing Mar 23, 2023

Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703…

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-8215-9 D-0521-2023

Class II · Moderate risk Ongoing Mar 23, 2023

Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC…

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-7971-3 D-0520-2023

Class II · Moderate risk Ongoing Mar 23, 2023

Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-7086-3); b) 90-count bottle (NDC 68788-7086-9), Rx…

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-7086-3 D-0519-2023

Class II · Moderate risk Ongoing Mar 23, 2023

Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC…

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-9438-3 D-0518-2023

Class II · Moderate risk Ongoing Mar 23, 2023

Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC…

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-8095-9 D-0517-2023

Class II · Moderate risk Ongoing Mar 23, 2023

Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6976-3); b) 90-count bottles (NDC 68788-6976-9), Rx…

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-6976-3 D-0516-2023

Class II · Moderate risk Ongoing Mar 23, 2023

Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7149-1

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-7149-1 D-0515-2023

Class II · Moderate risk Ongoing Mar 23, 2023

Doxazosin Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7328-1

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-7328-1 D-0514-2023

Class II · Moderate risk Ongoing Mar 23, 2023

Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC…

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-8190-9 D-0513-2023

Class II · Moderate risk Ongoing Mar 23, 2023

Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (NDC 68788-7631-9); b) 30-count bottle (NDC…

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-7631-9 D-0512-2023

Class II · Moderate risk Ongoing Mar 23, 2023

Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC…

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-7630-9 D-0511-2023