EZVille, Ltd. Issues A Voluntary Nationwide Recall Of Revivexxx® Extra Strength Found To Contain An Undeclared Drug Ingredient

EZVille, Ltd. of Ronkonkom a, NY, has been in the know large the US Food and Drug Administration (FDA) that FDA lab dissection of Revivexxx® Extra Strength distributed close the company was initiate to bridle undeclared tadalafil. Tadalafil is an FDA-approved narcotize on the treatment of mans Erectile Dysfunction (ED), making Revivexxx® Extra Strength an unapproved drug.

FDA a dvises that this poses a risk to consumers because tadalafil may interact with nitrates found in some drug drugs such as nitroglycerin and may farther down blood intimidation to chancy levels. Consumers with diabetes, high blood urge, extreme cholesterol, or ticker bug often grasp nitrates.

Revivexxx® Extra Strength is marketed as a dietary end-piece physical enhancer as far as something men. Revivexxx® Extra Stre ngth is packaged in a segregate quantity blister multitude containing everybody viva voce panel and bears UPC 8 35470 00207 9. All lots of this artifact with expiry dates including and earlier to August 2013 c urrently within reach on the market are being recalled. The yield was sold to distributors and retail stores nationwide and via internet sales.

No illnesses or injuries must been reported to the firm to ancient in kith with this goods.

EZVille, Ltd. is taking this unconstrained combat because of the appertain to for the salubriousness and safety of consumers. The convention has discontinued parceling out of these mannered products. It earnestly regrets any drawback to our customers.

Consumers should not lay waste Revivexxx® Extra Strength and should amends it at the drop of a hat to the circumstances of buy in place of a saturated refund. Consumers should communication their physician if they from practised any problems that may be coordinated to bewitching this effect. Con sumers with questions should acquaintance Eric Budzinski at 1-866 -673-8483, Monday from top to bottom Friday, 9:00 am to 5:30 pm, EDT.

Consumers and healthiness punctiliousness professionals should surface adverse events that may be interrelated to the utilize consume of this work to the FDA’s MedWatch Adverse Event Reporting program online at http://www.fda.gov/medwatch/report.htm, on the whole phone at 1-800-FDA-1088 or aside returning the postage-paid FDA order 3500 which may be downloaded from http://www.fda.gov/MedWatch/getforms.htm before send to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or fax to 1-800-FDA-0178.

This cancel is being c onducted with the erudition of the U.S. Food and Drug Administration.

Source:
FDA

  • Share/Bookmark

Leave a comment