Recall Issued for Male Lifestyle Drug, FDA Tests Reveal Undeclared Ingredient

Topics: Counterfeit drugs

Consumer Concepts, distributor of ROCK-It MAN Male Enhancement Capsules, has issued a voluntary recall of its product after FDA testing revealed an undeclared active ingredient, hydroxythiohomosildenafil, making it an unapproved new drug. The ingredient has a similar pharmacological and adverse event profile as sildenafil, the active pharmaceutical ingredient in Viagra® and similar drugs, which can lower blood pressure to dangerous levels when interacting with drugs that treat diabetes and high blood pressure. FDA advises those who bought the capsules, marketed as dietary supplements, between October 2012 and April 2013, to immediately cease use and return unused pills for a full refund. Additionally, FDA asks that health care providers report any adverse events to the FDA MedWatch program.