Fizogen Recalls Discontinued Product

WELLINGTON, Fla.Fizogen Precision Technologies announced a voluntary national recall of all lots of its Off Cycle II Hardcore, which was marketed as a dietary supplement and contains 3,17-keto-etiochol-triene, 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 in violation of federal law.

FDA informed Fizogen of potential adverse events associated with the use of aromatase inhibitors, 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.

Fizogen discontinued production of Off Cycle II Hardcore in July 2009; however, some retailers may still be selling remaining inventory. While the company has not received any adverse event reports associated with use of the product, it advised consumers to cease using the product and return the unused portion to the retail location where it was purchased or to Fizogen directly.

Consumers who do have adverse reactions to the use of Off Cycle II Hardcore can report the situation to FDA via the MedWatch Adverse Event Reporting program online.