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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 17321–17340 of 17,860 recalls

Class IITerminated

PredniSONE Tablets, USP, 10 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1473-01), b) 1000-count tablets per bottle (NDC 0143-1473-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724.

West-ward Pharmaceutical Corp.

Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets.

December 5, 2012 · DrugView details →
Class ITerminated

Cyanocobalamin 1000 mcg/ml, injection 30 mL, MDV, For Office Use Only, Green Valley Drugs, Manufactured by Green Valley Drugs, Henderson, NV.

Green Valley Drugs

Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of Methylprednisolone Preservative Free 40 mg/mL injectable suspension and one lot of Cyanocobalamin 1000 mcg/mL injection, 30 mL MDV.

December 4, 2012 · DrugView details →
Class IIITerminated

Clean & Clear advantage, 3-in-1 foaming wash 8 FL. OZ. (240 mL) bottle, OTC, Distributed in the US by: Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies Inc. Skillman, NJ 08558-9418 NDC 58232-0326-8

Johnson & Johnson

Superpotent (Single Ingredient Drug): salicylic acid

December 4, 2012 · DrugView details →
Class IITerminated

Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-328-09

Amedra Pharmaceuticals LLC

Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.

December 4, 2012 · DrugView details →
Class IITerminated

Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-329-09

Amedra Pharmaceuticals LLC

Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.

December 4, 2012 · DrugView details →
Class IITerminated

Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-327-09

Amedra Pharmaceuticals LLC

Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.

December 4, 2012 · DrugView details →
Class ITerminated

Methylprednisolone Preservative Free 40 mg/ml Injectible Suspension, 1 mL Vials and 2 mL Vials and 1 mL pre-filled syringes, For Office Use Only, Manufactured by Green Valley Drugs, Henderson, NV.

Green Valley Drugs

Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of Methylprednisolone Preservative Free 40 mg/mL injectable suspension and one lot of Cyanocobalamin 1000 mcg/mL injection, 30 mL MDV.

December 4, 2012 · DrugView details →
Class IITerminated

Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx Only, NDC 0074-7069-90; ABBOTT LABORATORIES NORTH CHICAGO, IL 60064 U.S.A.

Abbott Laboratories

Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.

December 4, 2012 · DrugView details →
Class IITerminated

Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-30, b) 100 tablets - NDC 61748-013-01, Mfd for: VersaPharm Incorporated Marietta, GA 30065-1505, Mfd by: West - Ward Pharmaceutical Corp.., Eatontown, NJ 07724

West-ward Pharmaceutical Corp.

Failed Dissolution Specifications; 36 month stability timepoint

December 4, 2012 · DrugView details →
Class IIITerminated

Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724, NDC 0143-1176-01.

West-ward Pharmaceutical Corp.

Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Register making this product a schedule IV (C-IV)controlled substance. This product is being recalled because this controlled product was not relabeled with the required "C-IV" imprint on the label for products distributed after the 06/11/12 deadline.

November 30, 2012 · DrugView details →
Class IITerminated

VERSAPHARM Ethambutol Tablets, USP,400 mg, Rx Only a)60 tablets, NDC 61748-014-06, b)90 tablets, NDC 61748-014-09, c)100 tablets, NDC 61748-014-01, d)1000 tablets, NDC 61748-014-10, e) blister pack (10s) 61748-014-11 Manufactured for: VersaPharm Incorporated Marietta, GA 30062-2260, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.

West-ward Pharmaceutical Corp.

Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.

November 30, 2012 · DrugView details →
Class IITerminated

Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1264-01) and b) 1000-count tablets per bottle (NDC 0143-1264-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.

West-ward Pharmaceutical Corp.

Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets.

November 30, 2012 · DrugView details →
Class IITerminated

NorthStar Arthritis Relief Cream. Net Wt. 2 oz tube, OTC, Manufactured for and Distributed by NewMarket Health Products, LLC. 702 Cathedral St. Baltimore, MD 21201

Mariposa Labs, LLC

Microbial Contamination of Non-Sterile Products: Arthritis Relief Cream failed microbiological specifications.

November 29, 2012 · DrugView details →
Class IIITerminated

TORISEL Kit (temsirolimus) injection, 25 mg/mL, CONCENTRATED, Rx Only, Packaged in a carton containing 1 vial TORISEL injection and 1 vial DILUENT for TORISEL, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA --- NDC 0008-1179-01

Pfizer Inc.

Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.

November 26, 2012 · DrugView details →
Class IITerminated

Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmaceutical Industries, Ltd. Haifa Bay, Israel 26110, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4118-6.

Taro Pharmaceuticals U.S.A., Inc.

Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.

November 21, 2012 · DrugView details →
Class IIITerminated

Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ONLY, NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE, Net Contents 118.28 mL (4 fl. oz.), Hill Dermaceuticals, Inc., Sanford, Florida --- NDC 28105-149-04

Hill Dermaceuticals, Inc.

Subpotent; 22 month stability timepoint

November 21, 2012 · DrugView details →
Class ITerminated

Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66), 10 x 100 mL (NDC 0270-1316-67), 10 x 125 mL (NDC 0270-1316-68) Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany).

Bracco Diagnostic Inc

Presence of Particulate Matter; fibers identified as cellulose and polyvinyl

November 21, 2012 · DrugView details →
Class ITerminated

Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany); NDC 0270-1315-67.

Bracco Diagnostic Inc

Presence of Particulate Matter; fibers identified as cellulose and polyvinyl

November 21, 2012 · DrugView details →
Class IIITerminated

Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill Dermaceuticals, Inc., Sanford, Florida 32773 --- NDC 28105-150-04

Hill Dermaceuticals, Inc.

Subpotent; 12 month stability timepoint

November 21, 2012 · DrugView details →
Class IITerminated

Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01

Hospira, Inc.

Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured.

November 21, 2012 · DrugView details →
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