SILVER SPRINGS, Nev.—Advanced Muscle Science announced a voluntary national recall of all lots of its products Arom-X, Arom-X UTT, Arom-XL, 4-AD and Devacol, all marketed as dietary supplements for testosterone boosting and sexual function. The products contain 1,4,6 etioallocholan-dione, known as ATD, an aromatase inhibitor that stops the body’s production of estrogen. FDA informed the company it does not believe ATD is a dietary ingredient, making the products in violation of federal law.
FDA informed Advanced Muscle Science 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.
Production of most of the products had been discontinued by Advanced Muscle Science more than a year ago. Arom-X capsules and 4-AD capsules, for example, were discontinued in March 2009; Arom-XL liquid was discontinued in February 2009, while Arom-X UTT liquid and Decavol capsules were discontinued by the company in January 2010. However, the company noted some retailers may be selling remaining inventory, thus triggering the recall notice. In addition, this voluntary recall does not include Arom-X RD or the current version of Arom-X liquid, neither of which contain ATD.
Advanced Muscle Science noted it has not received any adverse event reports associated with use of the recalled products, but advised consumers to cease using them and return unused portions to the company or retailer. Consumers who do have adverse reactions to any of the items can report the situation to FDA via the MedWatch Adverse Event Reporting program online.
This is the third recall notice announced by FDA concerning ATD content in dietary supplements in the last two days.