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FDA RECALLS & COURT ACTIONS: May 5, 1993

Executive Summary

CLASS II - CYTOTEC (MISOPROSTOL) TABLETS, 200 MCG In unit dose bottles of 60 and 100, in cartons of 100 unit dose tablets, and in physician sample packs of 12, an Rx oral tablet indicated for the prevention of NSAID-induced gastric ulcers. Recall number: D-246-3. Lot numbers: 3A382, 3B383, 3B383A, 3B384, 3B386. Manufacturer: G. D. Searle & Company, Gaguas, Puerto Rico. Recalled by: G. D. Searle & Company, Skokie, Illinois, by letter April 22, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; 39,276 physician samples, 368 unit dose cartons, 21,621 bottles of 100 and 6,128 bottles of 60 were distributed; firm estimates 60% of the product remains on the market. Reason: Presence of Pseudomonas bacteria. CLASS II - PERITRATE SA (PENTAERYTHRITOL TETRANITRATE) Sustained Action Tablets, in bottles of 100, indicated for the relief of angina pectoris. Recall number: D-245-3. Lot numbers: 16101VA, 07751VA, 07751VB. Manufacturer: Warner Lambert, Inc., Vega Baja, Puerto Rico. Recalled by: Parke Davis, Division of Warner- Lambert Company, Morris Plains, New Jersey, by letter April 12, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; Approximately 38,968 units were distributed. Reason: Lot 16101VA does not meet disintegration specifications. Lots 07751VA and 07751VB do not meet dissolution specifications.

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