Tuesday, June 07, 2011

Recall: VIA XTREME - a Dietary Supplement for Men

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From the FDA:

Global Wellness, LLC. Hollywood, FL is conducting a voluntary nationwide recall of VIA XTREME ULTIMATE SEXUAL ENHANCER DIETARY SUPPLEMENT FOR MEN to the consumer level. The product was distributed throughout the U.S. Puerto Rico, and Canada to internet and retail consumers.

The product is distributed as a bottle containing six (6) blue colored capsules per package. The label on the packaging lists the company name Global Wellness, LLC, Hollywood Florida. Only Lots 809013 and 806030 are covered in this recall.

The company has been informed by representatives of the Food and Drug Administration (FDA) that laboratory analysis conducted by FDA for Lots 809013 and 806030 found that the product contains sulfoaildenafil methanesulfonate, sulfosildenafil and dimethylsildenafil analogs of sildenafil. 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.