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Virility Max: Recall - Undeclared Drug Ingredient

Audience: Consumer

ISSUE: FDA lab analysis for Lot 10090571 found Virility Max to contain sulfoaildenafil, an analog of sildenafil. Sildenafil is an active ingredient of an FDA approved drug for erectile dysfunction (ED), making Virility Max 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.

BACKGROUND: Virility Max is marketed for sexual enhancement. It is distributed in 10 count, white plastic bottles to retail customers in the South Florida area.

RECOMMENDATION: Consumers who have this product in their possession should stop use immediately, and contact their physician if they have experienced any problems that may be related to taking this product.

[11/10/2011 - Press Release - Keime Inc]