This is to inform you of a product recall involving:
Gaspari Nutrition Incorporated, Novedex XT®,
All lots numbers/expiration dates, UPC Code 6-46511-00655-3
The recall has been initiated because the United States Food and Drug Administration does not believe that an ingredient contained in the product (3,17-keto-etiocholetriene, aka 'ATD') meets the definition of a dietary ingredient and therefore the FDA believes the product is in violation of provisions of the Food, Drug and Cosmetic Act.
The FDA believes use of this product may lead to decreased rate of bone maturation and growth, decreased sperm production, infertility, aggressive behavior, adrenal insufficiency, kidney failure, and liver dysfunction.
Gaspari Nutrition began shipping this product on January 22nd 2005.
We request that you immediately examine your inventory and quarantine this product subject to recall. In addition, if you may have further distributed this product, please try to identify your customers and notify them as soon as possible of this product recall. Notification of your customers may be enhanced by including a copy of this letter.
Please contact us by emailing service@bodybuilding.com, or calling 1-866-236-8417 to make appropriate arrangements regarding disposition of any product you have.
This recall should be carried out at all levels (e.g., distributor, wholesale, retail, and end consumer). Your assistance is appreciated and necessary to prevent potential customer adverse events.
If you have any other general questions about the product please contact us by emailing service@bodybuilding.com, or by calling 1-866-236-8417.
This recall is being made with the cooperation and knowledge of
The United States Food and Drug Administration.
