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FDA RECALLS & COURT ACTIONS: Sept. 22 & 29, 1993

Executive Summary

CLASS II -- NITROGLYCERIN EXTENDED RELEASE CAPSULES (a) 6.5 mg; (b) 2.5 mg, both packaged in 60- and 100-capsule bottles, for the prevention of angina pectoris due to coronary artery disease. Recall number: D-340/341-3. Lot numbers: 6.5 mg, 60-capsule bottle -- V3117, EXP 3/95. 6.5 mg, 100-capsule bottle -- V2706, EXP 1/95; V2887, EXP 1/95; V2888, EXP 1/95; V2891, EXP 2/95; V289Z EXP 2/95; V2893, EXP 2/95; V2895, EXP 2/95; V2896, EXP 2/95; V2897, EXP 3/95; V2898, EXP 3/95; V3091, EXP 3/95.2.5 mg, 60-capsule bottle -- V1433, EXP 2/94; V2250, EXP 8/94; V2747, EXP 11/94. 2.5 mg, 1 00-capsule bottle -- V2501, EXP 12/94; V2504, EXP 12/94; V3005, EXP 1/95. Manufacturer KV Pharmaceutical Company, St. Louis, Missouri. Recalled by- Ethex Corporation, St. Louis, Missouri, by letter Sept. 17, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; (a) 417 cases (12 60-capsule bottles per case) and 781 cases (12 100-capsule bottles per case); (b) 3,801 cases (12 60-capsule bottles per case) and 159 cases (12 100-capsule bottles per case) were distributed. Reason: Lack of adequate assurance of potency through expiration date. CLASS II -- PAPAVERINE HCL TIME RELEASE CAPSULES 150 mg, in 100 and 1,000 capsule bottles, Rx, under Schein and Danbury labels. Recall number D-342-3. Lot numbers: 41517D EXP 11/93, 41368D EXP 9/93, 41675D EXP 1/94, 42021D EXP 5/94. Manufacturer Danbury Pharmacal, Inc., Danbury, Connecticut. Recalled by: Manufacturer, by letter Sept. 9, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; lot number 41517D estimated 200 100-capsule bottles under the Danbury Pharmacal Inc. label; estimated 25 1,000- capsule bottles under the Danbury Pharmacal Inc. label; lot number 41368D estimated 10 100-capsule bottles under the Schein Pharmaceutical Inc. label; estimated 20 100-capsule bottles under the Danbury Pharmacal Inc. label; estimated 2 1,000-capsule bottles under the Schein Pharmaceutical Inc. label; lot number 41675D estimated 1,000 100-capsule bottles under the Danbury Pharmacal Inc. label; estimated 35 1,000-capsule bottles under the Danbury Pharmacal Inc. label; lot number 42021D estimated 4,000 100-capsule bottles under the Danbury Pharmacal Inc. label. Reason: Product does not meet dissolution specifications. CLASS II -- PROCAINAMIDE HCL EXTENDED RELEASE TABLETS 750 mg, in bottles of 100 and 500, Rx, under Schein and Danbury labels. Recall number: D-343-3. Lot number 43761D EXP 3/95. Manufacturer: Danbury Pharmacal, Inc., Danbury, Connecticut. Recalled by: Manufacturer, by letter Sept. 9, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; 700 100-tablet bottles and 200 500-tablet bottles were distributed. Reason: Product does not meet dissolution specifications. CLASS III -- NATUS PATCH Pain Relief Patches for fast, temporary relief of pain, containing methyl salicylate 11%, menthol 2%, and camphor 3.5%, in boxes of 30. Recall number: D-339-3. All lots. Manufacturer LecTec Corporation, Minnetonka, Minnesota. Recalled by: Natus Corporation, Edina, Minnesota, by letter Sept. 15, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; 271,350 units were distributed. Reason: Potency not assured through expiration date. CLASS III -- SMX-TMP SS Sulfamethoxazole 400 mg/trimethoprim 80 mg single strength tablets, Rx antibacterial, with indications and usage for treatment of urinary tract infections, acute otitis media, chronic bronchitis and others. Recall number: D-338-3. Lot numbers: 0G010, Exp. Date 10/93; 0H034, Exp. Date 11/93; 0K069, Exp. Date 2/94; 1A066, Exp. Date 6/94; 1C067, Exp. Date 8/94; 1F011, Exp. Date 10/94; 1K022, Exp. Date 1/95; 1L041, Exp. Date 2/95; 2C046, Exp. Date 5/95; 2E049, Exp. Date 8/95; 2G035, Exp. Date 9/94; 2J010, Exp. Date 4/95; 2M014, Exp. Date 4/95; 3B062, Exp. Date 6/95; 3C020, Exp. Date 7/95. Manufacturer Eon Labs Manufacturing Inc., Laurelton, New York. Recalled by: Manufacturer, by letter on or about Sept. 10, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; approximately 38,682 bottles were distributed. Reason: Overage of the trimethoprim ingredient.
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