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Executive Summary

COUNTERFEIT NAPROSYN: THREE OF FOUR SUSPECTS PLEAD GUILTY to production and distribution in a criminal suit brought by FDA in California Federal Court. Two of the three have been sentenced and the fourth is awaiting trial. Over 1,200 bottles of counterfeit Naprosyn seized by FDA were traced to the four suspects, who operated in Los Angeles under the name of Naghdi Group. FDA's investigation began in late March. The counterfeit product contained acetaminophen and/or aspirin instead of naproxen. During April and May, FDA filed seizure actions in California, New York, Oregon, Louisiana, Indiana, Texas and Virgina for roughly 1,232 bottles of 500 tablets each. Syntex announced in April that it had requested FDA's assistance in locating and seizing the counterfeit Naprosyn ("The Pink Sheet" April 13, T&G-6). Syntex said in a recent statement that it is pursuing a separate civil lawsuit to collect unspecified punitive damages and to recover costs. Syntex said it is sending "a message to any counterfeiters that the company will use every available remedy to prosecute individuals involved in the manufacture and supply of products that illegally carry the Syntex name." The firm added: "We are pleased that the criminal investigation of individuals involved in the manufacture and supply of a limited amount of counterfeit naproxen tablets has been forcefully and expeditiously carried out by the United States Food and Drug Administration and the United States Department of Justice."

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