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CECLOR(END ITALICS) LOTS DISTRIBUTED BY QUALITY KING BEING RECALLED

Executive Summary

CECLOR(END ITALICS) LOTS DISTRIBUTED BY QUALITY KING BEING RECALLED "because some ]of the capsules[ may be counterfeit or unauthorized foreignmade versions of the drug," FDA announced in a Sept. 27 "Talk Paper." The agency noted that the Quality King supplies of Lilly's Ceclor (cefaclor) went to nine retailers and whslrs: Eagel Drug Inc. Rx of Eden Prairie, Minn.; Giant Rx Distributors of Baltimore, Md.; K&B Rx of Metairie, La.; H.L. Moore Co. Rx of New Britain, Conn.; Northwestern Drug of Auburn, Wash.; Revco of Dallas, Texas; Revco of Knoxville, Tenn.; Snyder Drug Warehouse of Eagen, Minn., and Mark Stevens Rx of Woonsocket, R.I. FDA said "at least two of the Quality King-distributed lots have a different appearance and different lot numbers from those used by Lilly." The lot numbers for the recalled products are 9BQ56A for the 250 mg capsules and 8TSl2B for the 500 mg capsules. FDA noted that the alleged counterfeit Ceclor is also identifiable by the capsule shape (Quality King-distributed products have a hemispheric shape while Lilly's are bullet-shaped); the absence of the product name and dosage strength on the capsule; and by the expiration date, the month of which is fully spelled out on the counterfeit label and abbreviated on the authentic Lilly label. FDA also noted that eight other Lilly lots distributed by Quality King are being recalled by the distributor because "their source and condition of storage are not certain." These lot numbers are: 8EW84B, 8FA25B, 7PC88A, 8EG63A in the 250 mg strength, and 8ED12A, 8DB43A, 7SS14A, 7PG44A in the 500 mg strength. The agency explained that "other Ceclor packages may bear these eight lot numbers but are NOT suspect and NOT being recalled IF their source was a regular Lilly distributor or any other distributor but Quality King and their sub-distributors." Quality King began recalling the Ceclor products Sept. 23. On Sept. 26, Lilly filed suit against the firm in the federal court of New York for trademark infringement and unfair competition. The court issued a same-day temporary restraining order that bars Quality King from distributing products with Lilly's Ceclor trademark. Lilly's suit states that Quality King and its President Bernard Nussdorf imported and sold to U.S. retail pharmacies "certain quantities of cefaclor antibiotic, which is prominently identified by ]Lilly's[ trademarks Ceclor and LlLLY, which imitates the labeling used by ]Lilly[ on the Ceclor product sold in the U.S., and which otherwise represents that ]Lilly[ is the source of the drug product so labeled and packaged whereas in fact said product has been rebottled and repacked by some entity other than ]Lilly[ or any company authorized by ]Lilly[." Lilly's complaint is the second suit filed against Deer Park, NY-based Quality King in the past month. The whslr. was named with the Polish government company DAL Internatl. in a suit brought by J&J over the diversion of J&J's Reach toothbrushes and baby products ("The Pink Sheet" Sept. 16, T&G-9). J&J claimed that DAL fraudulently purchased the J&J products by representing that it intended to sell the products solely in Poland and in fact distributed them in the U.S. via Quality King. In issuing a preliminary injunction to restrain movement of the J&J goods, Newark Federal Judge Dickinson Debevoise stated that "while the evidence does not show that Quality King participated in the fraud, it cannot be held to be a bonafide purchaser."

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