V Maxx RX: Recall - Undeclared Drug Ingredient

Posted 05/29/2012]

AUDIENCE: Consumer

ISSUE: The Menz Club, LLC issued a nationwide recall of V Maxx Rx due to undeclared sulfoaildenafil. Sulfoaidenafil is an analog of sildenafil, an FDA approved prescription drug used to treat Erectile Dysfunction (ED), making V Maxx Rx an unapproved new drug.

FDA advises that this poses a threat to consumers because sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. The firm has not received any reports of adverse events related to this recall.

BACKGROUND: The affected products may have been ordered online at www.vmaxxrx.com  or www.themenzclub.net and were distributed to customers and distributors nationwide. This product is marketed as a dietary supplement intended for use as a male enhancement product and is packaged in one (1) and five (5) count blister packs and ten (10) count bottles. For product lot numbers please see the firm press release.

RECOMMENDATION: The Menz Club, LLC is notifying its customers and distributors by email and/or phone to return or destroy all recalled products. Any consumer having V Maxx Rx should immediately stop using it and destroy the unused product or return it to ATTN: Product Returns, The Menz Club, LLC, P. O. Box 906, Madison, MS 39110.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[05/25/2012 - Press Release - Menz Club, LLC]