ST LOUIS (MD Consult) - On August 6, 2010, the US Food and Drug Administration (FDA) announced that EZVille, Ltd has recalled Revivexxx Extra Strength, a product marketed as a dietary supplement for sexual enhancement in men. The decision to conduct the recall was made after the FDA informed the company that a product analysis revealed the presence of undeclared tadalafil. Tadalafil is an FDA-approved drug for the treatment of male erectile dysfunction, making Revivexxx Extra Strength an unapproved drug.

The FDA believes that the use of this product could pose a threat to consumers because tadalafil may interact with nitrates found in some prescription drugs (eg nitroglycerin) and may lower blood pressure to dangerous levels. However, no illnesses or injuries have been reported to the company to date in connection with this product.

Revivexxx Extra Strength is packaged in a single-dose blister pack containing 1 oral tablet and bears Universal Product Code 8 35470 00207 9. All lots of this product with expiration dates including and prior to August 2013 currently available on the market are being recalled. The company has discontinued distribution of the affected product.

Consumers are being advised to contact their physician if they have experienced any problems that may be related to use of this product. Health care professionals and patients are encouraged to report adverse events related to product use to the FDA's MedWatch Program.