FDA RECALLS & COURT ACTIONS: November 17, 1993

Executive Summary

CLASS II -- DMSA KIDNEY REAGENT KIT For the preparation of Technetium TC99m Succimer Injection, Rx intravenous sterile diagnostic radiopharmaceutical. Recall number: D-023-4. Lot numbers: 002, 002A, 002B. Manufacturer Amersham International plc, Gloucester, England. Recalled by: Medi-Physics, Inc., Arlington Heights, Illinois, by letter Oct. 12, 1993. Firm- initiated recall ongoing. Distribution: Nationwide, Canada; 724 kits were distributed; firm estimates 150 kits remain on the market. Reason: Kits bear an expiration date of March 24, 1994 instead of Sept. 24, 1993. CLASS II -- VIDEX (DIDANOSINE) CHEWABLE/DISPERSIBLE BUFFERED TABLETS, 25 MG In 60 tablet bottles, Rx, used in the treatment of AIDS. Recall number D-025-4. Batch code MBE15. Manufacturer: Bristol-Myers Squibb Company, Evansville, Indiana. Recalled by: Bristol-Myers Squibb HIV Products, Princeton, New Jersey, by letter June 3, 1993. Firm- initiated recall complete. Distribution: Nationwide; 207 cases (12 bottles per case) were distributed. Reason: Product does not meet content uniformity specifications. CLASS III -- NOVAFED Brown and orange colored hard gelatin capsules, in bottles of 100, a controlled-release Rx decongestant. Recall number: D-024-4. Lot number 1127BC EXP 12/94. Manufacturer: KV Pharmaceuticals, St Louis, Missouri. Recalled by: Marion Merrell Dow, Inc., Cincinnati, Ohio, by letter Oct. 7, 1993. Firm-initiated recall ongoing. Distribution: Nationwide and Puerto Rico; 19,467 bottles were distributed; firm estimates very little stock remains on the market. Reason: Product failed stability testing for dissolution.