V Maxx RX Recall
| Date: | May 25, 2012 |
| What: | V Maxx RX |
| Why: | Contains a prescription drug |
| Scope: | Nationwide |
The Menz Club is recalling V Maxx RX with the following lot numbers:
- V Maxx RX, single count, UPC 2802803561, Lot Nos. 101108, 101009, 101010, 101011
- V Maxx RX five count, UPC 0972859402, Lot Nos. 101108, 101109, 101110
- V Maxx RX ten count, UPC 0913251017, Lot Nos. 301000, 301001
An FDA lab analysis of V Maxx Rx Lot #101109 distributed by The Menz Club was found to contain undeclared sulfoaidenafil. 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. The Menz Club is recalling the above listed lots of V Maxx RX which can pose a serious risk to health. (Additional lots are being recalled since the product has the same formulation.)
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 Menz Club has not received any reports of adverse events related to this V Maxx Rx recall. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using these products.
V Maxx RX 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.
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, PO Box 906, Madison, MS 39110. Customers with questions may call (601) 866-6746, Monday through Friday, 9:00 a.m. - 4:30 p.m. Central time for further instructions or information with respect to the return process.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program by:
- Online: www.fda.gov/medwatch/report.htm
- Fax: 800-FDA-0178
- Phone: 800-FDA-1088
- Regular Mail: use postage-paid FDA form 3500 available at www.fda.gov/MedWatch/getforms.htm and mail to:
MedWatch, FDA
5600 Fishers Lane
Rockville, MD 20852-9787
Consumers with questions about food safety can Ask Heidi, a certified food safety professional.
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