|
Date
|
Product Description
|
Reason/ Problem
|
Company
|
Details
|
|
02/18/2011
|
Various drugs
|
Mislabeled bottles
|
Upsher-Smith Laboratories, Inc.
|
|
|
02/16/2011
|
Warfarin Sodium, USP, 3mg Tablets
|
Mislabeled Bottles: 10mg strength tablets found in bottle labeled for 3mg tablets
|
Upsher-Smith Laboratories, Inc.
|
|
|
02/05/2011
|
a) Hydrocodone Bitartrate and Acetaminophen Tablets b)Phenobarbital Tablets
|
Bottle may be incorrectly labeled
|
Qualitest Pharmaceuticals
|
|
|
02/04/2011
|
Watson’s Trelstar (triptorelin pamoate for injectable suspension) product, containing alcohol prep pads
|
Contain alcohol prep pads that were recently recalled by the Triad Group due to potential contamination with Bacillus cereus
|
Watson Pharmaceuticals, Inc.
|
|
|
02/03/2011
|
Sodium Thiosulfate Injection, USP, 10%
|
Particles consistent with glass delamination
|
American Regent, Inc.
|
|
|
02/03/2011
|
Potassium Phosphates Injection, USP, 15 mM/5 mL Phosphorus; 22 mEq/5 mL Potassium
|
Particles consistent with glass delamination
|
American Regent, Inc.
|
|
|
01/31/2011
|
Fruta Planta weight loss dietary supplements
|
Sibutramine, an undeclared drug ingredient
|
Godi International, Corp.
|
|
|
01/26/2011
|
Relistor kit containing alcohol prep pads
|
Contains potentially contaminated alcohol prep pads
|
Pfizer Inc. and Progenics Pharmaceuticals, Inc.
|
|
|
01/24/2011
|
ARIXTRA Starter Kit containing alcohol prep pads
|
Contains potentially contaminated alcohol prep pads
|
GlaxoSmithKline
|
|
|
01/24/2011
|
Celerite Slimming Capsules
|
Sibutramine, an undeclared drug ingredient
|
Shaping Beauty, Inc.
|
|
|
01/20/2011
|
Betaseron kit containing alcohol prep pads
|
Contains potentially contaminated alcohol prep pads
|
Bayer HealthCare Pharmaceuticals
|
|
|
01/18/2011
|
Nite Rider Maximum Sexual Enhancer For Men and STUD Capsules for Men Male Enhancement Herbal Supplement Capsules Marketed as Dietary Supplements
|
Adulterated with Sildenafil, an FDA approved drug used in the treatment of Erectile Dysfunction (ED), making the products unapproved new drugs
|
Kanec USA
|
|
|
01/14/2011
|
TYLENOL® 8 Hour, TYLENOL® Arthritis Pain, and TYLENOL® upper respiratory products, and certain lots of BENADRYL®, SUDAFED PE®, and SINUTAB®
|
Production records found instances where equipment cleaning procedures were insufficient or that cleaning was not adequately documented.
|
McNeil Consumer Healthcare
|
|
|
01/13/2011
|
Medicine Kits
|
Kits contain alcohol prep pads that were recently recalled by the Triad Group due to potential contamination with Bacillus cereus
|
Genentech, Inc.
|
|
|
01/10/2011
|
Extavia kit containing alcohol prep pads
|
Contain alcohol prep pads that were recently recalled by the Triad Group due to potential contamination with Bacillus cereus
|
Novartis Pharmaceuticals Corporation
|
|
|
01/06/2011
|
Metronidazole Tablets
|
Underweight Tablets
|
Teva Pharmaceuticals, U.S.A
|
|
|
01/05/2011
|
Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks
|
Bacillus cereus
|
Triad Group
|
|