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-August 28, 2008
According to reports, the FDA requested that U.S. Marshalls seize an estimated $74,000 worth of Xiadafil tablets today.
The two seized lots, which are distributed by SEI Pharmaceuticals, Inc., were being marketing illegally.
FDA Takes Action
Lots 6K029 and 6K209-SEI are being seized today due to the fact that they contain an undeclared ingredient.
The FDA supposedly requested SEI recall the lots in May; however, the medication was still being given away at trade shows and sold in eight tablet bottles.
The company reportedly refused to recall the products and now the FDA took action to prevent additional tablets of Xiadafil from being marketed and sold.
Xiadafil Causes Concern
Xiadafil has been marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement.
However, the drug was never approved for the treatment of ED by the FDA and the overall safety and effectiveness of the drug has been questioned.
Agency Ensures Drug Doesn’t Cause Harm
“Today’s seizure action shows that FDA will take enforcement action to protect the public from dietary supplements that contain prescription drug ingredients that are potentially harmful to consumers,” explains Margaret O’K Glavin, the associate commissioner of the FDA’s Office of Regulatory Affairs.
The FDA has also issued a warning that consumers should discontinue their use of Xiadafil VIP tablets and seek medical attention if they feel they have suffered from side effects of the drug.
(Source: Pharmaceutical Online)
Have you been harmed by Xiadafil VIP tablets? If so, please contact us to speak with an experienced attorney who will evaluate your case and ensure you receive the legal help you need.