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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

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 II

Terminated

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 →

Class IITerminated

Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Direct Rx

cGMP deviations

March 13, 2023 · DrugView details →

Class IITerminated

Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Direct Rx

cGMP deviations

March 13, 2023 · DrugView details →

Class IITerminated

Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Direct Rx

cGMP deviations

March 13, 2023 · DrugView details →

Class IITerminated

Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC 61919-0250-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Direct Rx

cGMP deviations

March 13, 2023 · DrugView details →

Class IITerminated

Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC 61919-0448-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Direct Rx

cGMP deviations

March 13, 2023 · DrugView details →

Class IITerminated

Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Direct Rx

cGMP deviations

March 13, 2023 · DrugView details →

Class IITerminated

Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Direct Rx

cGMP deviations

March 13, 2023 · DrugView details →

Class IITerminated

Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx

Direct Rx

cGMP deviations

March 13, 2023 · DrugView details →

Class IITerminated

Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Direct Rx

cGMP deviations

March 13, 2023 · DrugView details →

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