Posted August 13, 2010

Recall of Male Enhancement Supplement Sold in National Stores

On August 9, 2010 the U.S. FDA announced that the company Prolatis' of Salt Lake City, Utah is conducting a voluntary recall of the company's product sold as Prolatis'. The FDA had informed the company that lab analysis found Prolatis’ to contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED), making Prolatis’ an unapproved drug. The active drug ingredient is not listed on the product label. Product manufactured prior to August 9, 2010 is included in this recall.

Prolatis’ is sold nationwide in double blister packs and 40 count bottles.

This recall is being conducted as a precautionary measure. No illnesses or adverse effects have been reported to the company to date in connection with this product.

The undeclared ingredient may pose a threat to consumers because the analogue 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. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Prolatis’ advises any customer in possession of Prolatis’ to return the product for a full credit towards the new product.