Gaspari Nutrition Incorporated just announced that it is conducting a voluntary, nationwide recall of all lot codes of its dietary supplement product sold under the name <"http://www.yourlawyer.com/practice_areas/defective_drugs">Novedex XT, the US Food and Drug Administration (FDA) just announced.
Novedex XT was marketed “for increasing natural testosterone production” and contains 3,17-keto-etiocholetriene, also known as ATD, an anti-aromatase.
Gaspari Nutrition is conducting this consumer-level recall after being informed by representatives of the FDA that 3,17-keto-etiocholetriene does not meet the definition of a dietary ingredient and that the product is, therefore, in violation of provisions of the Federal Food, Drug, and Cosmetic Act (FDCA).
Potential adverse events associated with the use of anti-aromatases could include the following: Decreased rate of bone maturation and growth, decreased sperm production, infertility, aggressive behavior, adrenal insufficiency, kidney failure, and liver dysfunction. Consumers with liver, kidney, adrenal, or prostate abnormalities are at higher risk for developing adverse events.
Novedex XT had been sold internationally and domestically, to distributors, wholesalers, retail stores, and direct to consumers, but was discontinued by Gaspari Nutrition for domestic sales on October 4th, 2010. The product was sold in blue bottles with a black cap, containing 60 capsules.
Consumers who have Novedex XT in their possession should stop using it immediately. If consumers experience any adverse side effects due to consumption of this product, they should immediately contact a physician. Adverse reactions or quality problems experienced with the use of this product may be reported to Gaspari Nutrition and to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax:
â€¢ Online: www.fda.gov/MedWatch/report.htmâ€¨
â€¢ Regular Mail: use postage-paid, preaddressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm
â€¢ Fax: 1-800-FDA-0178.
The Company is advising consumers who have Novedex XT to return any unused portion to the retail location from which it was purchased or, if purchased directly from Gaspari Nutrition, to return any unused portion to: Gaspari Nutrition Incorporated, 575 Prospect Street – Suite 230, Lakewood, NJ 08701; Attention: Novedex XT Recall.
Gaspari Nutrition can be reached at 1-732-364-3777, Monday through Friday, 9:00 a.m. t 5:00 p.m., Pacific Standard Time.