that it is conducting a voluntary nationwide recall of all Lot Codes of the company's dietary supplement product sold under the name Novedex XT, which 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 Food and Drug Administration (FDA) that 3,17-keto-etiocholetriene does not meet the definition of a dietary ingredient and therefore the product is in violation of provisions of the Federal Food, Drug, and Cosmetic Act.
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. Gaspari has received no serious adverse events in over five years of marketing Novadex XT.
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 sixty (60) capsules.
