【转帖】中国制药够乱吗？看看老美就不以为然了
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July 24, 2008
Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product
在企业拒绝召回产品的条件下，联邦当局查没Xiadafil VIP片。
Product contains undeclared ingredient that could harm consumers
产品中含有未声明的可能伤害消费者的组分。
At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $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 erectile dysfunction (ED，勃起功能障碍) and for sexual enhancement, these lots represent an illegally marketed drug非法上市的药品 containing an undeclared ingredient.
Today's action follows a formal FDA request to SEI Pharmaceuticals (SEI) on May 27, 2008, to recall the lots of Xiadafil VIP tablets. The products were given away at trade shows and sold in eight tablet bottles (Lot # 6K029) and blister cards of two tablets (Lot # 6K029-SEI) bearing an expiration date of September 2009 (09/09). The company, however, refused to recall these products拒绝召回这些产品, making the seizure action necessary to prevent additional, illegal Xiadafil VIP products from entering the marketplace.
The FDA's chemical analysis of Xiadafil VIP tablets Lots # 6K029/6K029-SEI found that the product contains hydroxyhomosildenafil, which is chemically similar to sildenafi西地那非l. Sildenafil is the active ingredient in Viagra万艾可, an FDA-approved prescription drug for ED. The FDA has not approved Xiadafil VIP for ED or any other drug use, and the safety and effectiveness of this product is unknown. Although offered for sale as dietary supplements, the seized articles are new drugs that may not be introduced into interstate commerce without an approved new drug application filed with FDA.
"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," 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/FDA不能忍受公司不采取主动召回措施 to protect the public health after being given the opportunity by FDA to do so," she added.
On April 22, 2008, the FDA initiated an inspection at SEI Pharmaceuticals following its analysis of the Xiadafil VIP tablets. The company was advised of the FDA's findings and informed of the potential adverse health risks the product posed to unsuspecting consumers. The FDA also warned the company of possible legal actions, including seizure and/or injunction/FDA还警告过公司可能的法律行动，包括查没和命令 if corrective and preventive actions were not implemented. Although the company committed to halting distribution of the product and deactivated its Internet site, it refused to recall the product already in the market.
On May 13, 2008, Florida state officials issued a "stop sale禁售" action at SEI's distribution facility to keep the illegal product out of the marketplace. This action required SEI to hold, intact, violative Xiadafil VIP tablets found at the facility.
Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product
在企业拒绝召回产品的条件下，联邦当局查没Xiadafil VIP片。
Product contains undeclared ingredient that could harm consumers
产品中含有未声明的可能伤害消费者的组分。
At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $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 erectile dysfunction (ED，勃起功能障碍) and for sexual enhancement, these lots represent an illegally marketed drug非法上市的药品 containing an undeclared ingredient.
Today's action follows a formal FDA request to SEI Pharmaceuticals (SEI) on May 27, 2008, to recall the lots of Xiadafil VIP tablets. The products were given away at trade shows and sold in eight tablet bottles (Lot # 6K029) and blister cards of two tablets (Lot # 6K029-SEI) bearing an expiration date of September 2009 (09/09). The company, however, refused to recall these products拒绝召回这些产品, making the seizure action necessary to prevent additional, illegal Xiadafil VIP products from entering the marketplace.
The FDA's chemical analysis of Xiadafil VIP tablets Lots # 6K029/6K029-SEI found that the product contains hydroxyhomosildenafil, which is chemically similar to sildenafi西地那非l. Sildenafil is the active ingredient in Viagra万艾可, an FDA-approved prescription drug for ED. The FDA has not approved Xiadafil VIP for ED or any other drug use, and the safety and effectiveness of this product is unknown. Although offered for sale as dietary supplements, the seized articles are new drugs that may not be introduced into interstate commerce without an approved new drug application filed with FDA.
"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," 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/FDA不能忍受公司不采取主动召回措施 to protect the public health after being given the opportunity by FDA to do so," she added.
On April 22, 2008, the FDA initiated an inspection at SEI Pharmaceuticals following its analysis of the Xiadafil VIP tablets. The company was advised of the FDA's findings and informed of the potential adverse health risks the product posed to unsuspecting consumers. The FDA also warned the company of possible legal actions, including seizure and/or injunction/FDA还警告过公司可能的法律行动，包括查没和命令 if corrective and preventive actions were not implemented. Although the company committed to halting distribution of the product and deactivated its Internet site, it refused to recall the product already in the market.
On May 13, 2008, Florida state officials issued a "stop sale禁售" action at SEI's distribution facility to keep the illegal product out of the marketplace. This action required SEI to hold, intact, violative Xiadafil VIP tablets found at the facility.
