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Executive Summary

COUNTERFEIT OVULEN-21 RESURFACES IN FOXMEYER WAREHOUSE, CUSTOMER PHARMACIES, HHS announced in a Sept. 27 press release. According to the release, FDA has advised consumers in Texas and Oklahoma that counterfeit Ovulen-21 contraceptive tablet refills bearing the lot number -489 have been found in distribution in the two states. "FoxMeyer officials say they do not know how ]the[ suspect product came into its possession. . .but 50 counterfeit Ovulen-21 refills with the -489 lot number have been located in FoxMeyer-supplied pharmacies in the two states and five cartons were found in a FoxMeyer warehouse," HHS reported. Searle recalled two lots of Ovulen-21 (441 and 489) last November after the company and FDA were alerted that counterfeit versions of the contraceptive were in trade channels ("The Pink Sheet" Nov. 5, 1984 T&G-3). Like the products first recalled by Searle, the second batch of counterfeits has been found to be subpotent. Searle told whslrs. in November that counterfeit Ovulen lot 441 was in distribution in 1984 by Interstate Drug Exchange of Plainview, New York, and from Interstate to other unauthorized whslrs. According to HHS, none of the two suspect lots were found in FoxMeyer's possession last fall.

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