Gaspari Recalls Product with ATD

LAKEWOOD, N.J.Gaspari Nutrition Inc. announced a voluntary national recall of all lots of its Novedex XT, which was marketed as a dietary supplement to increase natural testosterone production." The product contains 3,17-keto-etiocholtriene, or ATD, an aromatase inhibitor that stops the bodys production of estrogen. FDA informed the company it does not believe 3,17-keto-etiochol-triene is a dietary ingredient, making the product adulterated. Several similar recalls of products containing ATD were announced in September 2010.

FDA informed Gaspari Nutrition of potential adverse events associated with the use of anti-aromatases, including infertility, adrenal insufficiencies, and kidney and liver dysfunction. The agency concluded products containing aromatase inhibitors are likely to cause adverse reactions in at-risk consumers, including those with liver, kidney, adrenal or prostate concerns.

Gaspari Nutrition noted it has not received any adverse event reports associated with use of the product. However, it advised consumers to cease using the product and return the unused portion to the retail location where it was purchased or to Gaspari Nutrition directly.

Consumers who do have adverse reactions to the use of Novedex XT can report the situation to FDA via the MedWatch Adverse Event Reporting program online.