FDA Recalls & Court Actions: April 25, 1990

Executive Summary

CLASS I -- H.L. MOORE BRAND WARFARIN 5 mg tablets, an Rx blood thinner, in bottles of 100. Lot numbers: G873-01, G685-08. Manufacturer: Pharmaceutical Basics Inc. (PBI), Denver, Colorado. Recalled by: Manufacturer, by telephone March 29-30, 1990 followed by letter March 29, 1990. Firm-initiated recall ongoing. Distribution: Nationwide, Virgin Islands, Puerto Rico. 600 bottles were distributed. Reason: A bottle of H.L. Moore's brand Warfarin Sodium 5 mg Tablets was found mislabeled as H.L. Moore brand Desipramine HCl 25 mg tablets. CLASS III -- LILLY ERGOTRATE MALEATE BRAND ERGONOVINE MALEATE TABLETS, USP 0.2 mg, in bottles of 100 and 1,000, and ID-100 unit dose cartons (10 strips of 10 blisters each), an oral Rx drug indicated for the prevention and treatment of postpartum and postabortel hemmorrhage due to uterine atony. Lot numbers: 2RD02A EXP 6/1/90, 2RD02B EXP 6/1/90, 2RD02C EXP 6/1/90, 2RR22A EXP 9/1/90. Manufacturer: Eli Lilly and Company, Indianapolis, Indiana. Recalled by: Manufacturer, by letter March 9, 1990. Firm-initiated recall ongoing. Distribution: Nationwide, Netherlands, Dominican Republic, Bermuda, Virgin Islands, Haiti, Australia. 17,495/100 tablet bottles (lot 2RD02A), 8,005/100 unit dose cartons (lot 2RD02B), 1,137/1000 tablet bottles (lot 2RD02C), 35,614/100 tablet bottles (lot 2RR22A) were distributed; firm estimates very little to none remains on market. Reason: Product does not meet USP related alkaloids test. SEIZURE ACTIONS FILED -- NYSTATIN POWDER Change, Subpotent. Firm: Paddock Laboratories, Inc., Minneapolis, Minnesota, Filed: Feb. 6, 1990 - U.S. District Court for the District of Minnesota; Civil #6-90-66, FDC #65803. SEIZURE ACTION FILED -- ZANTAC TABLETS, 150 MG Charge: Counterfeit. Firm: World Medical and Surgical Supply Corp., Flushing, New York. Filed: April 12, 1990 - U.S. District Court for the Eastern District of New York; Civil #CV-90-1262; FDC #65749.