Novacare Products Recalled for Undeclared Drug Ingredient

Washington, DC: Novacare LLC has been notified by the FDA that certain of its products appear to contain sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction. "Sulfoaildenafil" is not declared on the product labels.

Products affected are sold under the following names: 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).

The undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

The recalled products listed above were distributed in bottles and/or "blister cards" to retailers and via internet sales. All lots of the above-named products with manufacture or distribution dates prior to June 17, 2010 are being recalled.

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Published on Aug-11-10