LEDERLE's PIPERACILLIN WITH COUNTERFEIT U.S. LABELING IS SUBJECT OF RECALL BY TWO DISTRIBUTORS: NEW YORK SEIZURE ACTION INITIATED AFTER RECALL

Quantities of Lederle's piperacillin sodium is being recalled by two firms, Rx Wholesale Suppliers, located in Miami, Fla., and Habarx Distributing Corp., located in Hauppauge, N.Y. due to counterfeit labeling. The counterfeiting is part of a drug diversion scheme in which a Lederle product intended for sale overseas was diverted, relabeled, and sold in the U.S. A seizure complaint was filed in the Eastern District Court of New York against counterfeit piperacillin products March 11. In an affadavit attached to the complaint, Irene Ortiz, Internal Complaine Manager for Lederle Piperacillin, American Cyanamid's Puerto Rican subsidiary, explained that Lederle markets piperacillin under two different tradenames, Pipril and Pipracil. She said Pipril is labeled "predominantly in languages other than English and is sold exclusively outside the U.S." and Pipracil is labeled in English and marketed principally in the U.S. and Canada. Ortiz testified that she examined two groups of piperacillin samples, given to her by an FDA representative, that had English labels under the tradename Pipracil. She said the samples bore counterfeit labels which "were not manufactured, approved or affixed by Lederle." Ortiz stated that the vials originally had Spanish labels under the trade name Pipril when they were shipped by Lederle from Carolina, Puerto Rico "destined to a customer in Honduras." She noted that the counterfeit labels had false control numbers and other discrepancies, such as the typeface of the printing. Circulars and printed portions of trays accompanying the samples were also found to be counterfeit, Ortiz said. FDA's April 9 "Enforcement Report" notes that Habarx recalled piperacillin lost by letter March 3. The report also cites the Miami Beach, Fla. firm Military Exchange B.O., Inc., also known as Homosepes, as the "responsible firm." The agency's March 19 "Enforcement Report" notes that Rx Wholesale Suppliers initiated a recall by telephone Jan. 21. The recall involved 762 trays (25 vials/tray). The govt.'s seizure complaint notes that Rx Wholesale shipped piperacillin with counterfeit labeling to Quality King Distributors, located in Deer Park, N.Y., via a Quality King truck. Quality King has previously been cited as a distributor in counterfeit cases involving Lilly's Ceclor and Johnson & Johnson's Reach toothbrushes and baby products ("The Pink Sheet" Sept. 30, T&G-3, and Sept. 16, T&G-9). Lilly filed suit against Quality King and its President Bernard Nussdorf charging that they imported and sold to U.S. retail pharmacies quantities of cefaclor identified by Lilly's Ceclor trademark that had been rebottled by an unauthorized company. FDA Center for Drugs & Biologics Office of Compliance Director Dan Michels mentioned the diversion of piperacillin at a Ohio Pharmaceutical Seminar in Columbus April 14. He maintained that two Lederle employees were involved in diverting six shipments of piperacillin. Lederle was one of several firms cited at a September hearing before Chairman Dingell's (D-Mich.) House Commerce/Oversight Subcmte. as having products in the diversion market ("The Pink Sheet" Sept. 23, p. 14). Former Lederle representative Ed Burklow testified that due to intracorporate sales competition, Lederle opened a sales account "without any concern as to the eventual destination" of the products involved. Burklow said he had a side business selling Rx products to a hospital buying group, Pharmacy Resources, which resold the products to whslrs. According to Burklow, Lederle regional and natl. sales managers gave Pharmacy Resources permission to buy merchandise for export.