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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 581–600 of 1,000 recalls

Class IIITerminated

Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-047-24.

Baxter Healthcare Corporation

Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.

August 1, 2018 · DrugView details →
Class IIITerminated

Testosterone 200 mg Pellet, Rx only, Carie Boyd's Prescription Shop 122 Grapevine Hwy., Hurst, TX 76054, 800-930-4361

Right Value Drug Stores, Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect expiration date on label

July 26, 2018 · DrugView details →
Class IIITerminated

Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01

Lupin Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.

July 26, 2018 · DrugView details →
Class IIITerminated

Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC a) 36000-002-10 and b) 36000-002-06.

Renaissance Lakewood, LLC

Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.

July 11, 2018 · DrugView details →
Class IIITerminated

Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India; NDC 36000-003-06.

Renaissance Lakewood, LLC

Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.

July 11, 2018 · DrugView details →
Class IIITerminated

Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-002-10.

Renaissance Lakewood, LLC

Failed Stability Specifications: lot out of specification for elevated water vapor.

July 11, 2018 · DrugView details →
Class IIITerminated

Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with lubricating jelly and instructions for use per carton, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807; Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215; NDC 68682-650-20.

Valeant Pharmaceuticals North America LLC

Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.

July 10, 2018 · DrugView details →
Class IIITerminated

Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc. Morgantown, WV 26505, NDC 0378-1352-01

Mylan Pharmaceuticals Inc.

Subpotent Drug

July 9, 2018 · DrugView details →
Class IIITerminated

Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30

Aidarex Pharmaceuticals LLC

Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.

June 27, 2018 · DrugView details →
Class IIITerminated

Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90

Aidarex Pharmaceuticals LLC

Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.

June 27, 2018 · DrugView details →
Class IIITerminated

Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90

Aidarex Pharmaceuticals LLC

Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.

June 27, 2018 · DrugView details →
Class IIITerminated

Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054; Distributed by: MAJOR Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152; NDC 0904-5502-61.

MAJOR PHARMACEUTICALS

Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.

June 26, 2018 · DrugView details →
Class IIITerminated

Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054; Distributed by: MAJOR Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152; NDC 0904-5609-61.

MAJOR PHARMACEUTICALS

Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.

June 26, 2018 · DrugView details →
Class IIITerminated

Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-390-01 Carton [68084-390-11 - Unit Dose]

AMERICAN HEALTH PACKAGING

Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant

June 25, 2018 · DrugView details →
Class IIITerminated

Enalapril Maleate Tablets USP; 5 mg NDC code 64679-924-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons.

Wockhardt Limited

Failed Impurities/Degradation Specifications

June 19, 2018 · DrugView details →
Class IIITerminated

Enalapril Maleate Tablets USP; 2.5 mg NDC code 64679-923-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons.

Wockhardt Limited

Failed Impurities/Degradation Specifications

June 19, 2018 · DrugView details →
Class IIITerminated

Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC Parsippany, NJ 07054 USA, NDC 30698-911-15

Validus Pharmaceuticals, Inc.

Subpotency: lower than expected potency result was obtained at the 18 month stability time point.

June 15, 2018 · DrugView details →
Class IIITerminated

Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59

Validus Pharmaceuticals, Inc.

Subpotency: lower than expected potency result was obtained at the 18 month stability time point.

June 15, 2018 · DrugView details →
Class IIITerminated

Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged in a) 119 g bottle (NDC 49035-312-07), b) 238 g bottle (NDC 49035-312-08), Distributed by: Wal-mart Stores, Inc., Bentonville, AR 72716

LUPIN SOMERSET

Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ ClearLax Polyethylene Glycol 3350 NF Powder Solution of various sizes.

June 13, 2018 · DrugView details →
Class IIITerminated

Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 55111-123-05), Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA

Dr. Reddy's Laboratories, Inc.

Failed Impurities/Degradation Specifications

June 12, 2018 · DrugView details →
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