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FDA Drug Recalls

17,898 recalls, newest first

Class III · Low risk Terminated Mar 27, 2023

Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip tip syringe, each Syringe supplied in individually…

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.

Pine Pharmaceuticals, LLC NDC 69194-0458-1 D-0531-2023

Class III · Low risk Terminated Mar 27, 2023

Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva…

Reason Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.

Teva Pharmaceuticals USA Inc NDC 0093-7487-56 D-0510-2023

Class II · Moderate risk Terminated Mar 27, 2023

Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7596-3), b) 60-count bottle (NDC68788-7596-6); Rx…

Reason CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.

Preferred Pharmaceuticals, Inc. NDC 68788-7596-3 D-0506-2023

Class II · Moderate risk Terminated Mar 27, 2023

Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7595-3), b) 60-count bottle (NDC 68788-7595-6), c)…

Reason CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.

Preferred Pharmaceuticals, Inc. NDC 68788-7595-3 D-0505-2023

Class II · Moderate risk Terminated Mar 27, 2023

Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge…

Reason CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.

Preferred Pharmaceuticals, Inc. NDC 68788-7594-3 D-0504-2023

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

Class II · Moderate risk Ongoing Mar 22, 2023

Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC…

Reason CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.

Direct Rx NDC 72189-121-60 D-0509-2023

Class II · Moderate risk Ongoing Mar 22, 2023

Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only…

Reason CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.

Direct Rx NDC 72189-213-30 D-0508-2023

Class II · Moderate risk Ongoing Mar 22, 2023

Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC…

Reason CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.

Direct Rx NDC 72189-0240-30 D-0507-2023