EZVille, Ltd. Recall
Nationwide Recall of Dietary Supplement Found to Contain an Undeclared Drug Ingredient
On August 6, 2010, the U.S. Food and Drug Administration (FDA) issued the following recall information for a dietary supplement distributed by New York based EZVille, Ltd. FDA testing of the dietary supplement determined that the product contained an FDA-approved drug used to treat erectile dysfunction.
Consumers with cardiac problems are at risk for serious and potentially life-threatening side effects if they suffer a heart attack or other cardiac emergency and are treated with nitroglycerin.
The FDA recall information follows.
EZVille, Ltd. of Ronkonkoma, NY, has been informed by the US Food and Drug Administration (FDA) that FDA lab analysis of Revivexxx® Extra Strength distributed by the company was found to contain undeclared tadalafil. Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making 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.
No illnesses or injuries have been reported to the company to date in connection with this product.
EZVille, Ltd. is taking this voluntary action because of the concern for the health and safety of consumers. The company has discontinued distribution of these affected products. It sincerely regrets any inconvenience to our customers.
Consumers should not consume Revivexxx® Extra Strength and should 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, EDT.
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.
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