COUNTERFEIT ZANTAC SEIZURE INVOLVES 1,454 BOTTLES

Executive Summary

COUNTERFEIT ZANTAC SEIZURE INVOLVES 1,454 BOTTLES labeled as Glaxo's "Zantac 150." Each bottle contains 60 tabs. Following the filing of an April 12 complaint by Glaxo alleging that certain Zantac 150 tablets were counterfeit and liable to seizure, a U.S. marshall retrieved the bottles from FDA's New York district office. According to the complaint, which was filed in Brooklyn Federal Court, FDA originally seized the product, on July 21, from World Medical and Surgical Supply Corp. of Flushing, New York, and from E.M. Sales, Inc. of Farmingdale, New York. Glaxo's manager of package engineering Bruce Cohen examined the inner seals of the bottles and determined that the product had not been packaged by Glaxo. Cohen's examination, the complaint says, "revealed that said seals differed from authentic Glaxo seals with respect to the adhesion method utilized and with respect to typeface and style of the imprinted 'Glaxo' tradename logo." Therefore, Cohen found that the seals "were not authentic 'Glaxo' seals and that defendent article of drug was not packaged or distributed by Glaxo." Since Glaxo "did not authorize the use" of its name for the product, it is "a counterfeit drug" under the FD&C Act, the complaint states. World Medical had initiated a recall of various drugs including Zantac in late July because of "lack of assurance of product origin and authenticity" ("The Pink Sheet" Aug. 28, 1989, T&G-16). World Medical, which conducts business as Elm Drugs and First Providers, said that it purchased the drugs from a drug store that was going out of business.