Supplement Lots Seized After Company Fails to Issue Recall
At the FDA's request, U.S. marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc., of Miami. Xiadafil is marketed as a dietary supplement to treat erectile dysfunction (ED) and to enhance sex, according to the FDA. Chemical analysis of the illegal lots found that the product contains hydroxyhomosildenafil, which is chemically similar to sil-denafil.
The FDA has not approved Xiadafil VIP for ED or any other use, and thus these lots may not be introduced into interstate commerce without an FDA-approved New Drug Application.
Seizure by the marshals followed a formal FDA request on May 27 to recall the potentially harmful lots. The company refused to issue the recall, however, making the seizure necessary to prevent more illegal Xiadafil VIP products from entering the marketplace.