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7/30/2004

Counterfeit Zocor, Carisoprodol Found in U.S., FDA Warns

Donna Young

The Food and Drug Administration (FDA) today warned consumers and health care providers about the discovery of counterfeit versions of Zocor, Merck's cholesterol-lowering simvastatin product, and carisoprodol, a muscle relaxant.

The products, which were purchased at "Mexican border town pharmacies," were imported into the United States by Americans, the agency reported in a statement.

A spokesperson confirmed that some of the counterfeit drugs were sold to U.S. residents in Algodones, Mexico. FDA did not identify the states in which the Americans who purchased the fake products live.

The agency was notified about the counterfeit products through its MedWatch voluntary reporting system by Merck and West-Ward Pharmaceuticals, the spokesperson said.

The counterfeit 40-mg Zocor has a lot number of K9784, expiration date November 2004, and the counterfeit 350-mg carisoprodol has a lot number of 68348A. No expiration date was provided by FDA for the fake carisoprodol.

Tests of the phony Zocor indicated that the product did not contain any active ingredient, the agency said.

The counterfeit carisoprodol differed in potency when compared to the authentic product, FDA added.

"Patients who rely on these counterfeit versions of the drugs could develop serious health risks," the agency's statement declared. "FDA has repeatedly expressed its concern about the purchase by Americans of drugs from foreign countries. As demonstrated by this incident, purchasers cannot assume that the products meet the quality, efficacy, and safety standards of FDA authorized products or that FDA is assuring the quality, safety, and efficacy of products purchased from outside the United States."

FDA advised anyone who has purchased drugs with the lot numbers identified by the agency to contact their physicians and to notify their local FDA field office.

Tony Plohoros, spokesperson for Merck, said that his company received a report in May of counterfeit Zocor that was purchased in Mexico by a U.S. resident.

Plohoros said his company is aware of only one purchase of the fake product by one person and said that he did not know the state in which the person who obtained the counterfeit product lives.

Merck is not aware of anyone who has been sickened by the phony Zocor, he added. However, the FDA spokesperson said that Merck had reported to the agency that at least one patient's "cholesterol escalated."

"Regulatory authorities have been notified and Mexican authorities, and we are working with them," Plohoros said.

FDA is investigating the matter and working with Mexican authorities to "ensure that the further sale and importation of these products is halted," the agency said.