�At the request of the U.S. Food and Drug Administration, U.S. Marshals seized closely $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat cavernous dysfunction (ED) and for sexual sweetening, these tons represent an illegally marketed drug containing an undeclared ingredient.
Today's action follows a formal FDA request to SEI Pharmaceuticals (SEI) on May 27, 2008, to come back the gobs of Xiadafil VIP tablets. The products were apt away at trade shows and sold in eight tablet bottles (Lot # 6K029) and blister cards of deuce tablets (Lot # 6K029-SEI) bearing an expiration date of September 2009 (09/09). The company, however, refused to recall these products, making the seizure military action necessary to prevent extra, illegal Xiadafil VIP products from entering the market place.
The FDA's chemical analysis of Xiadafil VIP tablets Lots # 6K029/6K029-SEI establish that the product contains hydroxyhomosildenafil, which is chemically similar to sildenafil. Sildenafil is the active ingredient in Viagra, an FDA-approved prescription do drugs for ED. The FDA has not approved Xiadafil VIP for ED or any other drug usance, and the safety and effectiveness of this intersection is unnamed. Although offered for sale as dietary supplements, the seized articles are new drugs that may not be introduced into interstate highway commerce without an sanctioned new drug application filed with FDA.
"Today's capture action shows that FDA will shoot enforcement natural process to protect the public from dietary supplements that contain prescription drug ingredients that are potentially harmful to consumers," said Margaret O'K 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 afterwards being given the opportunity by FDA to do so," she added.
On April 22, 2008, the FDA initiated an inspection at SEI Pharmaceuticals undermentioned its analysis of the Xiadafil VIP tablets. The company was advised of the FDA's findings and informed of the voltage adverse health risks the product posed to unsuspicious consumers. The FDA as well warned the company of possible sound actions, including seizure and/or injunction if corrective and preventive actions were non implemented. Although the caller committed to halting distribution of the product and deactivated its Internet site, it refused to call back the mathematical product already in the mart.
On May 13, 2008, Florida state officials issued a "stop sale" action at SEI's distribution facility to observe the illegal product out of the marketplace. This action required SEI to hold, intact, violative Xiadafil VIP tablets found at the installation.
ED is a coarse problem in men world Health Organization have diabetes, high blood pressure, high cholesterol, or heart disease. Because they may have been well-advised against taking ED drugs, men with these conditions may seek alternative products like Xiadafil VIP tablets because they are marketed as "all natural" or as non containing the active ingredients in approved, prescribed ED drugs. Furthermore, because the manufacturing source of the active ingredients in many of these alternative products is strange, consumers should also be aware that the base hit, efficacy, and purity of these ingredients have not been verified by the FDA.
Consumers should quit the use of Xiadafil VIP tablets immediately and consult their health fear professional if they have experienced adverse events that they believe may be related to the enjoyment of this product.
Consumers and health care professionals can report adverse events to the FDA's MedWatch program online at hypertext transfer protocol://www.fDA.gov/medwatch/report.htm.
For more information, inspect:
www.fda.gov/consumer/updates/erectiledysfunction010408.html.
View drug information on Viagra.
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