FDA Drug Recalls

September 26, 2014 · DrugView details →

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only. Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC: 0591-0398-60, UPC 3 05910 39860 6.

Actavis Laboratories, FL, Inc.

Failed Tablet/Capsule Specifications: Presence of split or broken tablets.

September 26, 2014 · DrugView details →

Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles and 90-count bottles, RX only, Manufactured for Sun Pharma Global Inc. Dubai, United Arab Emirates by Sun Pharmaceutical Industries Limited, Halol, India

Sun Pharma Global Inc.

Failed Dissolution Specifications; 12 month stability time point

Class IITerminated

Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle/carton, and 12 bottles/trays, Professional Sample, Rx only, Forest Pharmaceuticals, Inc., St. Louis, MO. --- NDC 0456-1420-07

Forest Pharmaceuticals Inc

Failed Dissolution Specification; at the 6-month stability time point

September 26, 2014 · DrugView details →

Class IIITerminated

BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA, Inc. NDC: 68382-248-01

Zydus Pharmaceuticals USA Inc

Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.

September 24, 2014 · DrugView details →

September 22, 2014 · DrugView details →

LOSARTAN POTASSIUM TABLETS USP, 25 mg, 1000 Tablet Bottles, Rx Only. Manufactured by: Micro Labs Limited, Goa-403 722, INDIA. Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540. NDC 42571-110-10

Micro Labs Usa, Inc S

Failed Content Uniformity Specifications; Dry mix failed blend uniformity.

September 22, 2014 · DrugView details →

CEPHALEXIN MONOHYDRATE CAPSULES,USP, 500 mg, 20-count bottle, Rx only, Manufactured for Caraco Pharmaceuticals, Detroit, MI 48202 by Sun Pharmaceuticals, Fort Worth, TX 76155 and repackaged by Physicians Total Care, Inc., Tulsa, OK 74146-6233

Physicians Total Care, Inc.

CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not manufactured with good manufacturing practices.

Class IIITerminated

E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -count box, Rx Only, Manufactured in USA for E-Z EM, Inc. Lake Success, NY 11042 by Tower Laboratories LTD Centerbrook, CT 06409 NDC 10361-793-01

Bracco Diagnostic Inc

Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.

September 18, 2014 · DrugView details →

September 17, 2014 · DrugView details →

Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99

Janssen Ortho L.L.C.

Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.

Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01

Astellas Pharma US Inc

Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.

TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ USA 08534. NDC 68382-141-14.

Zydus Pharmaceuticals USA Inc

Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.

Assured Aspirin Enteric Safety Coated Tablets, 81 mg, Adult Low Strength, Pain Reliever (NSAID), 60-count bottle, Distributed by Greenbrier International, Inc., Chesapeake, VA 23320 UPC 639277018328.

American Family Pharmacy, LLC

Subpotent Drug: Product failed to meet USP Specifications on assay, content uniformity, and dissolution.

CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 Capsule Bottles, Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064, Product of Germany. NDC 0032-1224-07.

AbbVie Inc

Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.

September 12, 2014 · DrugView details →

Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, Rx only, Manufactured for Mylan Institutional, LLC, Rockford, IL 61103, NDC 67457-153-09.

Mckesson

Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distributing wholesalers.

Class IIITerminated

MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21) and b) 21 count blister pack (NDC 0603-4593-15), Rx only, Mfg for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811

Qualitest Pharmaceuticals

Subpotent; 6 month stability time point

September 11, 2014 · DrugView details →

September 11, 2014 · DrugView details →

HEPARIN SODIUM, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL flexible container unit, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7620-03

Hospira Inc.

Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between the tube and film at the round seal of the unused administrative port of the container.

September 9, 2014 · DrugView details →

Buprenorphine Hydrochloride Injection, CIII, 0.3 mg base/mL ,1 mL, 10 Carpuject Sterile Cartridge Units with Luer Lock, Slim-Paks, F Intramuscular or Intravenous Use, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2012-32

Hospira Inc.

Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point.

September 8, 2014 · DrugView details →

Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL Sterile single dose container bags, Rx only, Baxter USA, product code 2B0826, NDC 0338-0709-48.

Baxter Healthcare Corp

Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.

September 5, 2014 · DrugView details →

Ascorbic Acid 500 mg/mL Sterile Injection, 50mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.

Pharmacy Creations

Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.

September 5, 2014 · DrugView details →

Glutathione 100mg/mL Sterile Injection, 30 mL Multi Dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.

Pharmacy Creations

Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.