|
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 |
 |