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FDA Drug Recalls

1,122 recalls, newest first

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

Class II · Moderate risk Terminated Mar 20, 2023

Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-00), Rx…

Reason cGMP Deviations

RemedyRepack Inc. NDC 70518-0060-01 D-0503-2023

Class II · Moderate risk Terminated Mar 20, 2023

Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-00), Rx…

Reason cGMP Deviations

RemedyRepack Inc. NDC 70518-1311-01 D-0502-2023

Class II · Moderate risk Terminated Mar 20, 2023

Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-count bottles (NDC…

Reason cGMP Deviations

RemedyRepack Inc. NDC 70518-0375-03 D-0501-2023

Class II · Moderate risk Terminated Mar 20, 2023

Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00

Reason cGMP Deviations

RemedyRepack Inc. NDC 70518-3519-00 D-0500-2023

Class II · Moderate risk Terminated Mar 20, 2023

Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701…

Reason cGMP Deviations

RemedyRepack Inc. NDC 70518-2750-00 D-0499-2023

Class II · Moderate risk Terminated Mar 20, 2023

Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)90-count bottles (NDC 70518-1977-01), Rx…

Reason cGMP Deviations

RemedyRepack Inc. NDC 70518-1977-00 D-0498-2023

Class II · Moderate risk Terminated Mar 20, 2023

Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00

Reason cGMP Deviations

RemedyRepack Inc. NDC 70518-2972-00 D-0497-2023

Class II · Moderate risk Terminated Mar 20, 2023

Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 90-count bottles (NDC 70518-0064-00), Rx…

Reason cGMP Deviations

RemedyRepack Inc. NDC 70518-0064-01 D-0496-2023

Class II · Moderate risk Terminated Mar 20, 2023

Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00.

Reason cGMP Deviations

RemedyRepack Inc. NDC 70518-3519-00 D-0495-2023

Class II · Moderate risk Terminated Mar 20, 2023

Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC…

Reason cGMP Deviations

RemedyRepack Inc. NDC 70518-2439-00 D-0494-2023

Class II · Moderate risk Terminated Mar 20, 2023

Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b) 90-count bottles (NDC 70518-0405-00) and…

Reason cGMP Deviations

RemedyRepack Inc. NDC 70518-0405-03 D-0493-2023

Class II · Moderate risk Terminated Mar 20, 2023

Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) 90-count bottles (NDC 70518-1560-01), Rx only…

Reason cGMP Deviations

RemedyRepack Inc. NDC 70518-1560-00 D-0492-2023

Class II · Moderate risk Terminated Mar 20, 2023

Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottles (NDC 70518-1946-01), Rx…

Reason cGMP Deviations

RemedyRepack Inc. NDC 70518-1946-00 D-0491-2023

Class II · Moderate risk Terminated Mar 20, 2023

Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2921-03

Reason cGMP Deviations

RemedyRepack Inc. NDC 70518-2921-03 D-0490-2023

Class II · Moderate risk Terminated Mar 17, 2023

Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-179-03…

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Amerisource Health Services LLC NDC 68001-179-00 D-0759-2023

Class II · Moderate risk Terminated Mar 17, 2023

Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00; b) 500-count bottle; NDC# 68001-178-03…

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Amerisource Health Services LLC NDC 68001-178-00 D-0758-2023

Class II · Moderate risk Terminated Mar 17, 2023

Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b) 500-count bottle, NDC# 68001-177-03…

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Amerisource Health Services LLC NDC 68001-177-00 D-0757-2023