Global Wellness Recalls Sex Supplement

HOLLYWOOD, Fla.Global Wellness LLC issued a voluntary nationwide recall of Via Xtreme Ultimate Sexual Enhancer Dietary Supplement For Men after it was informed by FDA that lab analysis found the product contains sulfoaildenafil methanesulfonate, sulfosildenafil and dimethylsildenafil analogs of sildenafil. FDA conducted tests on lots 809013 and 806030 of the product, and those are the only two lots covered in the recall.

Silenafil is an active ingredient of an FDA approved drug for erectile dysfunction (ED), making Via Xtreme Ultimate Sexual Enhancer Dietary Supplement for Men an unapproved drug. The active drug ingredient is not listed on the product label.

The undeclared ingredient 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. Additionally, the product may cause side effects, such as headaches and flushing. No illnesses have been reported to Global Wellness LLC to date in connection with these products.

Silenafil is often found in containinated sexual health products. Last week, Intelli Health Products, Maitland, FL, was reprimanded by FDA for containing sulfoaildenafil and/or aildenafil, both of which are phosphodiesterase type-5 (PDE-5) inhibitors and analogues of sildenafil in its Duro Extend sexual health product. The week before, FDA sent a warning letter to Ethos Environmental, an Irvine, CA-based direct response marketer operating as Regeneca, due to laboratory analysis that showed the product contained sildenafil and an analogue.