Novacare Announces Voluntary Recall
August 11, 2010
MURRAY, Utah—Novacare LLC, which purchased TSN Labs Inc.'s assets after TSN shut down, announced a voluntary recall of 21 different products, after FDA informed the company the items, marketed as dietary supplements, were found to contain an undeclared drug ingredient. Under federal law, the presence of undeclared drugs in a product marketed as a dietary supplement makes such a product both adulterated and misbranded.
The recall notice posted by FDA stated the agency said the products, primarily marketed for men’s sexual function, appear to contain sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug for erectile dysfunction. The drug can adversely interact with other nitrates found in some prescription drugs, causing dangerous drops in blood pressure. The voluntary recall affects all lots of the following products with manufacture or distribution dates prior to June 17, 2010: Stiff Nights, Aziffa, Size Matters, Erex, Mojo, Hard Drive, Eyeful, Red Magic, Straight Up, Zotrex, Monster Excyte, WOW, Xaitrex, Verect, Prolatis, Xytamax, Maxyte, Libidinal, OMG, OMG45, and Zilex (with Golden Spear).
While no illnesses or adverse events have been reported to the company, customers should discontinue use of the products immediately and contact their health care provider if they have experienced any problems possibly related to their use. Adverse reactions or quality problems associated with use of the product can be reported via FDA’s MedWatch Adverse Event Reporting System.
Editor's Note: The first version of this story incorrectly stated FDA lab testing found the presence of sulfoaildenafil; the recall notice states FDA informed the company it believed the products contain sulfoaildenafil.