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FDA Drug Recalls

1,523 recalls · Class III, newest first

Class III · Low risk Terminated Sep 16, 2015

UN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113,

Reason CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.

Praxair Inc. D-0783-2016

Class III · Low risk Terminated Sep 16, 2015

UN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113, NDC 59579-006.

Reason CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.

Praxair Inc. D-0782-2016

Class III · Low risk Terminated Sep 10, 2015

ClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays of 5 tablets each) per carton, Rx only…

Reason Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.

EMD Serono, Inc. NDC 0093-0041-03 D-1813-2015

Class III · Low risk Terminated Sep 9, 2015

Bravelle 75 IU (urofollitropin for injection, purified) For Subcutaneous or Intramuscular Injection Only, 1 Carton (contains 5…

Reason Subpotent Drug

Ferring Pharmaceuticals Inc NDC 55566-8505-6 D-0015-2016

Class III · Low risk Terminated Aug 31, 2015

ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl oz (2mL), 1 Single Use Applicator Tip per…

Reason Falied pH specification

Oasis Medical, Inc. NDC 62144-5510-05 D-1418-2015

Class III · Low risk Terminated Aug 21, 2015

Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx only, Manufactured by: Silarx Pharmaceuticals, Inc…

Reason Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18)…

Silarx Pharmaceutical, Inc. NDC 54838-0566-70 D-1416-2015

Class III · Low risk Terminated Aug 21, 2015

Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only…

Reason Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed…

Akorn, Inc. NDC 50383-901-10 D-0295-2016

Class III · Low risk Terminated Aug 20, 2015

RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.

Reason Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.

Akorn, Inc. D-0231-2016

Class III · Low risk Terminated Aug 13, 2015

Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/80 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's…

Reason Subpotent Drug: Subpotent atorvastatin.

Dr. Reddy's Laboratories, Inc. D-1379-2015

Class III · Low risk Terminated Aug 13, 2015

Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count Bottles (NDC: 43598-315-30) and b) 90…

Reason Subpotent Drug: Subpotent atorvastatin.

Dr. Reddy's Laboratories, Inc. D-1378-2015

Class III · Low risk Terminated Aug 13, 2015

Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-318-30) and b) 90…

Reason Subpotent Drug: Subpotent atorvastatin.

Dr. Reddy's Laboratories, Inc. D-1377-2015

Class III · Low risk Terminated Aug 13, 2015

Amlodipine besylate and Atorvastatin calcium Tablets, 5 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-319-30) and b) 90…

Reason Subpotent Drug: Subpotent atorvastatin.

Dr. Reddy's Laboratories, Inc. D-1376-2015

Class III · Low risk Terminated Aug 13, 2015

Amlodipine besylate and Atorvastatin calcium Tablets,2.5 mg/40 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's…

Reason Subpotent Drug: Subpotent atorvastatin.

Dr. Reddy's Laboratories, Inc. D-1375-2015

Class III · Low risk Terminated Aug 13, 2015

Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/20 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's…

Reason Subpotent Drug: Subpotent atorvastatin.

Dr. Reddy's Laboratories, Inc. D-1374-2015

Class III · Low risk Terminated Aug 13, 2015

Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/10 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's…

Reason Subpotent Drug: Subpotent atorvastatin.

Dr. Reddy's Laboratories, Inc. D-1373-2015

Class III · Low risk Terminated Aug 13, 2015

AMPICILLIN CAPSULES, USP, 250 mg, 500 count bottles, Rx only, Manufactured for: DAVA Pharmaceuticals, Inc., Fort Lee, NJ, By…

Reason Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling.

Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals D-1350-2015

Class III · Low risk Terminated Aug 11, 2015

METHOCARBAMOL TABLETS, USP 500 mg, 500 Count Bottles, Rx Only. Manufactured by AustarPharma LLC, Edison, NJ 08837, USA, Packaged…

Reason Presence of Foreign Substance: Presence of hair.

Golden State Medical Supply Inc. D-1426-2015

Class III · Low risk Terminated Aug 5, 2015

Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles, Rx Only. Mfd by: Taro Pharmaceuticals, Inc., Brampton, Ontario…

Reason Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.

Taro Pharmaceuticals, Inc. D-1370-2015

Class III · Low risk Terminated Jul 28, 2015

Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC…

Reason Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution…

Novartis Pharmaceuticals Corp. D-1430-2015

Class III · Low risk Terminated Jul 28, 2015

Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Kabi USA…

Reason Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)

Fresenius Kabi USA, LLC NDC 63323-614-01 D-1327-2015

Class III · Low risk Terminated Jul 28, 2015

Meijer Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Dist. By Meijer Distribution Inc. 2929…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 41250-527-31 D-0039-2016

Class III · Low risk Terminated Jul 28, 2015

Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-coiunt tablets per box, (NDC 0363-0527-69, ITEM…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 0363-0527-69 D-0038-2016

Class III · Low risk Terminated Jul 28, 2015

Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 49348-930-01, UPC 0…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 49348-930-01 D-0037-2016

Class III · Low risk Terminated Jul 28, 2015

Up&Up loratadine orally disintegrating tablets, USP, 10 mg, 30-count tablets per box, Distributed by Target Corp, Minneapolis…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 11673-527-31 D-0036-2016

Class III · Low risk Terminated Jul 28, 2015

TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a) Children's 10-count tablets per box (NDC…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 36800-528-69 D-0035-2016