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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P05-57
August 31, 2005

Media Inquiries:
Catherine McDermott, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

Federal Authorities Cease Sale and Distribution of Counterfeit Lipitor

The U.S. Food and Drug Administration (FDA) and the United States Attorney for the Western District of Missouri, Kansas City, Missouri, today announced the indictments of 11 individuals, a drug repacker, and two wholesale distributors in cases related to the sale of Lipitor, a popular cholesterol reducing drug.

The indictment alleges numerous charges including conspiracy to sell counterfeit, illegally imported and misbranded drugs as well as conspiracy to sell stolen drugs. The conspiracy involved the manufacture of counterfeit Lipitor at a clandestine facility in Central America, the purchase of genuine Lipitor intended for distribution in South America, and the illegal importation into the United States of both products.

"This case demonstrates that the FDA will take the necessary steps to protect the drug supply in America," said FDA Commissioner Dr. Lester Crawford. "I am pleased that the U.S. Attorney’s Office and FDA have been able to put together this case and stop these fraudulent schemes to sell pharmaceuticals of unknown safety and efficacy to the public."

In 2003, Albers Medical Distributors, Kansas City, MO, (a drug wholesaler) distributed over $20 million in illegally imported and counterfeit Lipitor that was sold to H.D. Smith Wholesale Drug Company (Wood Dale, IL). H.D. Smith distributed these Lipitor tablets throughout the U.S. The counterfeit Lipitor was repackaged by Med-Pro, Lexington, NE., a drug repacker. All three participants in this scheme were named in the indictment today. It is believed that these counterfeit Lipitor products are out of circulation.

In addition, it is alleged in the indictment that members of the conspiracy distributed pharmaceuticals stolen from GlaxoSmithKline and Roche Pharmaceuticals and counterfeited drugs The FDA’s Office of Criminal Investigation (OCI) was able to put together the case by tracing back the various steps in this scheme. OCI was able to document where the chemicals and products came from, where the counterfeit was being manufactured, and how it was distributed.

Working together with the U.S. Attorney’s Office in the Western District of Missouri, these findings led to today’s indictment of all parties involved.

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