EZVille and the FDA announced a recall of all lots of Revivexxx Extra Strength, marketed as a dietary supplement sexual enhancer for men, after FDA lab analyses found the product to contain undeclared tadalafil. Tadalafil is an FDA-approved drug for the treatment of erectile dysfunction. Revivexx Extra Strength may 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. Consumers with diabetes, hypertension, hyperlipoproteinemias, or cardiac disease often take nitrates.
All lots of this product with expiration dates including and prior to August 2013 are being recalled. Consumers who have Revivexxx Extra Strength in their possession should stop using it immediately and contact their healthcare provider if they experience any adverse effects related to the use of the product.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm221687.htm.