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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 IIITerminated

Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only, Manufactured for: Claris LifeSciences, Inc. North Brunswick, NJ 08902 By: Claris Injectables Ltd., Gujarat, India

Renaissance Lakewood, LLC

Superpotent

November 11, 2017 · DrugView details →

Class IIITerminated

Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distributed by: Bayer Healthcare LLC Morristown, NJ 07962 NDC 0280-2160-36 UPC 3128431310577

Bayer HealthCare Pharmaceuticals, Inc.

Failed Stability Specifications

November 10, 2017 · DrugView details →

Class IIITerminated

Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 25 x 1 mL Vials per shelf pack (NDC 0641-6145-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA.

West-Ward Pharmaceuticals Corp.

Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).

November 6, 2017 · DrugView details →

Class IIITerminated

Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (2 mg/mL), 100 mL Flexible Bag, Manufactured for: Claris LifeScience Inc. North Brunswick NJ 08902 by Claris Injectables Ltd. Gujarat, India UPC 336000008242 NDC 36000-008-249

Claris Lifesciences Inc

Superpotent

November 6, 2017 · DrugView details →

Class IIITerminated

Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC 0641-6146-01), packaged in 25 x 5 mL Vials per shelf pack (NDC 0641-6146-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA.

West-Ward Pharmaceuticals Corp.

Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).

November 6, 2017 · DrugView details →

Class IIITerminated

bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC: 0378-2009-05

Mylan Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during routine stability testing.

November 3, 2017 · DrugView details →

Class IIITerminated

Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol, (lidocaine 4%, menthol 1%), Net Wt. 2.75 oz. (77.3 g) Tube, Distributed by: Ducere Pharma, LLC New Hope, PA 18938 USA --- UPC 849648000023

Dr. Reddy's Laboratories, Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt match the lot number printed on the bottle

October 30, 2017 · DrugView details →

Class IIITerminated

Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06

Jubilant Cadista Pharmaceuticals, Inc.

Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.

October 30, 2017 · DrugView details →

Class IIITerminated

Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023-9211-03; b) 5 mL (NDC# 0023-9211-05); c) 10 mL (NDC# 0023-9211-10); d) 15 mL (NDC# 0023-9211-15) bottles, Manufactured By: Allergan, Irvine, CA 92612..

Allergan Sales, LLC

Failed Impurities/Degradation Specifications.

October 19, 2017 · DrugView details →

Class IIITerminated

Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612. NDC# 0023-3205-03

Allergan Sales, LLC

Failed Impurities/Degradation Specifications.

October 19, 2017 · DrugView details →

Class IIITerminated

Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 0591-5884-01.

Teva Pharmaceuticals USA

Failed Dissolution Specifications: Low out of specification results for dissolution.

October 17, 2017 · DrugView details →

Class IIITerminated

Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmachemle, Swensweg 5, Haarlem, The Netherlands; Mfd for: Winthrop U.S., a business of sanofi-aventis U.S. LLC, Bridgewater, NJ 08807; NDC 0955-1746-01.

Sanofi-Aventis U.S. LLC

Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.

October 13, 2017 · DrugView details →

Class IIITerminated

Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd. by: Teva Pharmachemie Swensweg 5 Haarlem, The Netherlands Mfd. for: Genzyme Corporation, Cambridge, MA 02142, NDC 0024-5860-01.

Genzyme Corporation

Labeling: Incorrect or Missing Package Insert.

October 12, 2017 · DrugView details →

Class IIITerminated

Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy Acid Controller, NDC 55111-118-30, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, b) Equate Famotidine, NDC 49035-118-30, Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716, Made in India

Dr. Reddy's Laboratories, Inc.

Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval.

October 3, 2017 · DrugView details →

Class IIITerminated

morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per mL , For IV Use, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-455-78

Pharmedium Services, LLC

Labeling: Incorrect or Missing Lot and/or Exp. Date

September 26, 2017 · DrugView details →

Class IIITerminated

morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per mL (2 mg per 2 mL), For IV Use, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-259-28

Pharmedium Services, LLC

Labeling: Incorrect or Missing Lot and/or Exp. Date

September 26, 2017 · DrugView details →

Class IIITerminated

HYDROmorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 mg per mL, For IV Use Only, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-165-78

Pharmedium Services, LLC

Labeling: Incorrect or Missing Lot and/or Exp. Date

September 26, 2017 · DrugView details →

Class IIITerminated

Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per case containing a total of 5 mL x 30 Unit Dose Cups per case (NDC 68094-301-62), Rx only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080.

Precision Dose Inc.

Subpotent Drug: low out of specification results.

September 25, 2017 · DrugView details →

Class IIITerminated

Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-172-01

Amneal Pharmaceuticals, Inc.

Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.

September 25, 2017 · DrugView details →

Class IIITerminated

Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged in 10-count shrink wrap packs (NDC 0781-3407-95), Rx only, Manufactured in Austria by Sandoz GmbH or Sandoz Inc., Princeton, NJ 08540.

Sandoz Inc

Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.

September 25, 2017 · DrugView details →

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