EZVille, Ltd. of Ronkonkoma, New York was just informed by the US Food and Drug Administration (FDA) that its lab analysis of Revivexxx® Extra Strength was found to contain undeclared tadalafil. Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making <"https://www.yourlawyer.com/practice_areas/defective_drugs">Revivexxx® Extra Strength an unapproved drug.
FDA advises that this poses a threat to consumers because tadalafil 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.
Revivexxx® Extra Strength is marketed as a dietary supplement sexual enhancer for men. Revivexxx® Extra Strength is packaged in a single dose blister pack containing one oral tablet and bears UPC 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 product was sold to distributors and retail stores nationwide and via Internet sales. To date, no illnesses or injuries have been reported to the company in connection with this product.
The FDA is advising consumer not to consume Revivexxx® Extra Strength and to return it immediately to the place of purchase for a full refund. Consumers should contact their physician if they have experienced any problems that may be related to taking this product. Consumers with questions should contact Eric Budzinski at 1-866 -673-8483, Monday through Friday, 9:00 am to 5:30 pm, Eastern Daylight Time.
Consumers and health care professionals should report adverse events that may be related to the use of this product to the FDA’s MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm; by telephone at 1-800-FDA-1088; or by returning the postage-paid FDA form 3500, which may be downloaded from www.fda.gov/MedWatch/getforms.htm, either by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or by fax to 1-800-FDA-0178.
