FDA asks Xiadafil VIP Tabs be recalled

WASHINGTON, May 28 (UPI) -- The U.S. Food and Drug Administration said it has asked SEI Pharmaceuticals of Miami to recall all of its Xiadafil VIP Tabs.

The FDA said the recalled drug -- sold in 8 tablet bottles (Lot 6K029) or blister cards of 2 tablets (Lot 6K029-SEI) -- might contain a potentially harmful, undeclared ingredient that can cause life-threatening side effects.

The recalled lots of Xiadafil VIP Tabs bear an expiration date of "09/09". Xiadafil VIP Tabs are marketed as a dietary supplement for sexual enhancement and able to treat erectile dysfunction.

The federal agency said although labeled as a dietary supplement and touted as "all-natural," Xiadafil VIP Tabs are an illegally marketed drug that contains a potentially harmful undeclared ingredient -- hydroxyhomosildenafil -- that is an analog of sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for ED.

Federal officials said they have not approved Xiadafil VIP Tabs for ED or any other drug use, and its safety and effectiveness is unknown. The tabs were promoted and sold over the Internet, given away as free samples at trade shows and sold in health food stores nationwide.