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FDA RECALLS & COURT ACTIONS: Sept. 9, 1992

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Executive Summary

CLASS II -- ACETAMINOPHEN 325 mg tablets, Regular Strength Non-Aspirin Pain Reliever. Recall number: D-481-2. Lot number OE449, exp. date August 1993. Manufacturer: Life-Line Pharmaceuticals, Hayward, California. Recalled by: Manufacturer by letter June 24, 1992. Firm-initiated recall ongoing. Distribution: Pennsylvania and Tennessee; 6,462 units were distributed. Reason: Presence of metal shavings. CLASS II -- BULK NEOMYCIN SULFATE (POWDER), USP Recall number: D-479-2. Lot numbers: 765FY, 430HR; 073HT; 177FU; 178FU. Manufacturer: UpJohn Company, Kalamazoo, Michigan. Recalled by: Manufacturer by letter Aug. 18, 1992. Distribution: Nationwide and International; approximately 4,035 Kilograms were distributed. Reason: Elevated levels of sodium fluoride.

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