Keime Inc dba Barry’s Vitamins conducts a US nationwide voluntary recall of Virility Max Dietary Supplement: Lot Number 10090571. Keime Incorporated announced today that it is conducting a voluntary recall of one lot of the companies dietary supplement product sold under the following name: Virility Max. The company has been informed by representatives of the FDA that lab analysis by FDA for Lot 10090571, found the product contained 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 company has been informed by representatives of the FDA that lab analysis by FDA for Lot 10090571, found the product contained 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.
Virility Max is used for sexual enhancement. It is distributed in 10 count, white plastic bottles to retail customers in the South Florida area. No illnesses have been reported to the company to date in connection with this product.
More information may be found here.