"Stud Capsule For Men" Recalled

September 20, 2010

On April 2, Kanec USA Inc. (Davie, FL) issued a voluntary nationwide recall of its dietary supplement called Stud Capsule For Men, after being informed by FDA that laboratory analysis revealed a batch of the product to be adulterated with Sildenafil, an FDA-approved drug used in the treatment of erectile dysfunction. The presence of Sildenafil means that the dietary supplement is misbranded and is actually an unapproved new drug, according to the Federal Food, Drug, and Cosmetic Act.

On April 2, Kanec USA Inc. (Davie, FL) issued a voluntary nationwide recall of its dietary supplement called Stud Capsule For Men, after being informed by FDA that laboratory analysis revealed a batch of the product to be adulterated with Sildenafil, an FDA-approved drug used in the treatment of erectile dysfunction.

The presence of Sildenafil means that the dietary supplement is misbranded and is actually an unapproved new drug, according to the Federal Food, Drug, and Cosmetic Act.

FDA also added that use of the product 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, and heart disease often take nitrates, said FDA, and erectile dysfunction is a common problem in men with these conditions.