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FDA RECALLS & COURT ACTIONS: November 24, 1993

Executive Summary

CLASS II -- ULTRAVATE (HALOBETASOL PROPRIONATE) OINTMENT 0.05%, 50 g tubes, Rx topical corticosteroid. Recall number D-026-4. Lot number 145F016 EXP May 1996. Manufacturer: Westwood Squibb, Buffalo, New York. Recalled by: Manufacturer, by telephone followed by letters dated Oct. 27, 1993. Firm-initiated recall complete. Distribution: Nationwide; 394 cases (24 units per case) were distributed. Reason: A portion of the lot was adulterated with an equipment cleaning solution. CLASS III -- PERCODAN TABLETS In blister packs of 25, used for the relief of moderate to moderately severe pain. Recall number D-029-4. Lot EEA-00A1 EXP December 1994. Manufacturer: Dupont Merck Pharm, Manati, Puerto Rico. Recalled by: Manufacturer, by telephone Sept. 24, 1993, followed by letter. Firm-initiated recall complete. Distribution: Nationwide and Puerto Rico; 5,691 boxes containing 10 blister packs were distributed; firm estimates 75 boxes remain on the market. Reason: Aspirin component does not meet stability specifications for dissolution.
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