FDA RECALLS & COURT ACTIONS: September 15, 1993

Executive Summary

CLASS II -- CEFZIL (CEPROZIL HCL) 500 mg unit dose tablets, a broad spectrum antibiotic. Recall number: D-333-3. Lot numbers: B2V77A EXP 3/94, C2W64B EXP 4/94. Manufacturer: Bristol-Myers Carceloneta, Barceloneta, Puerto Rico. Recalled by: Bristol-Myers Squibb Company, New Brunswick, New Jersey, by letter dated Aug. 18, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; 922 units of lot B2V77A, 449 units of lot C2W64B were distributed. Reason: Strips of 500 mg unit- dose tablets were packaged in some cartons labeled as 250 mg. CLASS III -- KONDREMUL PLAIN In 16 ounce bottles, used for the temporary relief of constipation and sold under Fisons label. Recall number: D-337-3. Lot number RK2065 EXP 9/95 (Fisons lot 38487). Manufacturer: Barre-National, Inc., Baltimore, Maryland. Recalled by: Manufacturer, by letter April 7, 1993. Firm-initiated recall complete. Distribution: Now York; 60,864 units were distributed; firm estimates none remains on the market. Reason: Product fails stability specifications for total microbial count. CLASS III -- SODIUM POLYSTYRENE SULFONATE SUSPENSION, USP In 1 pint and 60 ml plastic bottles. Recall number: D-335-3. All lots. Manufacturer: Carolina Medical Products Company, Farmville, North Carolina. Recalled by: Manufacturer, by telephone Aug. 30, 1993, and by letter Aug. 31, 1993. Firm-initiated recall ongoing. Distribution: Canada; firm estimates 200 pint bottles and 75 10- bottle cartons of 60 ml bottles remain on the market. Reason: Use of non-approved formulation.