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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 2501–2520 of 17,723 recalls

Class IIOngoing

Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0240-30.

Direct Rx

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

March 22, 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 IIOngoing

Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC#: 67877-434-05

Ascend Laboratories, LLC

Out of specification (OOS) for Spectroscopic Identification test by IR.

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 IIIOngoing

Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL, Rx Only, Focus Health Group, Manufactured for: Focus Health Group, 5802 Kingston Pike, Knoxville, TN 37919. Incorrect NDC (kit): 24357-011-13

Focus Health Group Inc

Labeling; Incorrect NDC number on outer carton of product.

March 16, 2023 · DrugView details →

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