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FDA RECALLS & COURT ACTIONS: Nov. 10, 1993

Executive Summary

CLASS II -- ATENOLOL WITH CHLORTHALIDONE TABLETS 50 mg/25 mg, Rx used as a combination antihypertensive/diuretic, packaged in bottles of 100. Recall number D-018-4. Lot numbers: 25322 EXP July 1995 (Rugby & Mutual), 25323 EXP July 1995 (Mutual, URL & Geneva), 25324 EXP July 1995 (URL, Goldline, Mutual). Manufacturer: Mutual Pharmaceutical Company, Inc., Philadelphia, Pennsylvania. Recalled by: Manufacturer, by letter Sept. 15, 1993. Firm-initiated recall complete. Distribution: Nationwide; Lot number 25322 -- 1,662 bottles (Rugby), 1,675 bottles (Mutual); Lot number 25323 -- 352 bottles (Mutual), 144 bottles (URL), 4,320 bottles (Geneva); Lot number 25324 -- 288 bottles (URL), 49 bottles (Goldline), 809 bottles (Mutual). Reason: Product does not meet disintegration specifications. CLASS II -- CORTISONE ACETATE TABLETS, USP 10 mg and 25 mg, in bottles of 100, used as replacement therapy in adrenocortical deficiency states: Recall number D-021/022-4. Lot numbers: 982DF, 733HS (10 mg); 561FD, 616HJ, 535DW (25 mg). Manufacturer: The Upjohn Company, Kalamazoo, Michigan. Recalled by: Manufacturer, by letters Dec. 4, 1992 and Nov. 8, 1993. Firm- initiated recall ongoing. Distribution: Nationwide and international; 29,790 bottles of lot numbers 982DF, 733HS, 561FD and 616HJ and 14,539 bottles of lot numbers 535DW were distributed. Reason: Product does not meet dissolution specifications through expiration date. CLASS II -- LACRISERT A sterile Rx 5 mg Hydroxypropyl Cellulose Ophthalmic Insert and Applicator, indicated in patients with moderate to severe dry eye syndromes. Recall number: D-020-4. Lot number W0213. Manufacturer: Merck Manufacturing Division, Division of Merck & Company, Inc., West Point, Pennsylvania. Recalled by: Manufacturer, by letters beginning Nov. 4, 1993. Firm-initiated recall ongoing. Distribution: Nationwide and international; 4,077 units were distributed; firm estimates that very little if any of the product remains on the market. Reason: Lack of assurance of sterility.
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