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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 681–700 of 1,000 recalls

Class IITerminated

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) 90-count bottle (NDC 68788-7595-9); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL.

Preferred Pharmaceuticals, Inc.

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

March 27, 2023 · DrugView details →

Class IITerminated

Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 90-count bottles (NDC 70518-0064-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701

RemedyRepack Inc.

cGMP Deviations

March 20, 2023 · DrugView details →

Class IITerminated

Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC70518-2750-00

RemedyRepack Inc.

cGMP Deviations

March 20, 2023 · DrugView details →

Class IITerminated

Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701

RemedyRepack Inc.

cGMP Deviations

March 20, 2023 · DrugView details →

Class IITerminated

Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottles (NDC 70518-1946-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.

RemedyRepack Inc.

cGMP Deviations

March 20, 2023 · DrugView details →

Class IITerminated

Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b) 90-count bottles (NDC 70518-0405-00) and c)180-count bottles (NDC 70518-0405-02), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701

RemedyRepack Inc.

cGMP Deviations

March 20, 2023 · DrugView details →

Class IITerminated

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

RemedyRepack Inc.

cGMP Deviations

March 20, 2023 · DrugView details →

Class IITerminated

Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)90-count bottles (NDC 70518-1977-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.

RemedyRepack Inc.

cGMP Deviations

March 20, 2023 · DrugView details →

Class IITerminated

Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.

RemedyRepack Inc.

cGMP Deviations

March 20, 2023 · DrugView details →

Class IITerminated

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

RemedyRepack Inc.

cGMP Deviations

March 20, 2023 · DrugView details →

Class IITerminated

Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) 90-count bottles (NDC 70518-1560-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.

RemedyRepack Inc.

cGMP Deviations

March 20, 2023 · DrugView details →

Class IITerminated

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

RemedyRepack Inc.

cGMP Deviations

March 20, 2023 · DrugView details →

Class IITerminated

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

RemedyRepack Inc.

cGMP Deviations

March 20, 2023 · DrugView details →

Class IITerminated

Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-count bottles (NDC 70518-0375-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.

RemedyRepack Inc.

cGMP Deviations

March 20, 2023 · DrugView details →

Class IITerminated

Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2439-00.

RemedyRepack Inc.

cGMP Deviations

March 20, 2023 · DrugView details →

Class IITerminated

Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-179-03, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories

Amerisource Health Services LLC

CGMP Deviations: recalling drug products following an FDA inspection.

March 17, 2023 · DrugView details →

Class IITerminated

Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00; b) 500-count bottle; NDC# 68001-178-03 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. For BluePoint Laboratories

Amerisource Health Services LLC

CGMP Deviations: recalling drug products following an FDA inspection.

March 17, 2023 · DrugView details →

Class IITerminated

Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b) 500-count bottle, NDC# 68001-177-03; Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories

Amerisource Health Services LLC

CGMP Deviations: recalling drug products following an FDA inspection.

March 17, 2023 · DrugView details →

Class IITerminated

Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets (10 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-504-01; NDC Unit Dose: 60687-504-11, barcode (01) 003 60687 504 11 7.

Amerisource Health Services LLC

Failed Dissolution Specifications: Out of specification dissolution results above specified values.

March 16, 2023 · DrugView details →

Class IITerminated

Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61919-0723-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Direct Rx

cGMP deviations

March 13, 2023 · DrugView details →

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