July 29, 2008

Feds Seize Xiadafil VIP Tablets

The U.S. Food and Drug Administration said it has seized nearly $74,000 worth of Xiadafil VIP tablets because the company refused to recall the product.

U.S. marshals confiscated lots 6K029 and 6K209-SEI distributed by SEI Pharmaceuticals Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction and for sexual enhancement, the FDA said the lots represent an illegally marketed drug containing an undeclared ingredient.

The action followed a May 27 FDA request to the company to recall the tablets that were given away at trade shows and sold in eight-tablet bottles bearing an expiration date of September 2009. The FDA said the company refused to recall the products, making the seizure necessary to prevent additional, illegal Xiadafil VIP products from entering the marketplace.

The seizure shows the FDA will take enforcement action to protect the public from dietary supplements that contain prescription drug ingredients that are potentially harmful to consumers, said Margaret Glavin, associate commissioner of the FDA's Office of Regulatory Affairs.

FDA will not tolerate a company's failure to take voluntary action to protect the public health after being given the opportunity by FDA to do so, she added.