FDA RECALLS & COURT ACTIONS: June 9, 1993
Executive Summary
CLASS II - DOXEPIN HYDROCHLORIDE CAPSULES, USP (a) 100 mg, in bottles of 100; (b) 150 mg, in bottles of 50, a Rx anti-depressant. Recall number: D-272/273-3. Control numbers: 346-154 EXP 11/94; 346-155 EXP 12/94. Manufacturer: Lederle Arzneimittel Cyanamid GmbH, Germany. Recalled by: Lederle Laboratories, Division of American Cyanamid Company, Pearl River, New York, by letter May 21, 1993. Firm-initiated recall ongoing. Distribution: Alabama, Arkansas, Colorado, Connecticut, Florida, Louisiana, Maine, Pennsylvania, Kentucky, New Jersey, Virginia, West Virginia, South Carolina, Tennessee, Texas; (a) 1,201 bottles; (b) 1,553 bottles were distributed. Reason: Products do not meet dissolution specifications. CLASS III CHLOROMYCETIN CREAM, 1% (CHLORAMPHENICOL CREAM, USP) In 1 ounce tubes, Rx topical used for the treatment of surface skin infections. Recall number: D-271-3. Lot number 00172B EXP 7/93. Manufacturer: Parke-Davis Canada, Inc., Ontario, Canada. Recalled by: Warner-Lambert Company, Parke-Davis Division, Morris Plains, New Jersey, by letter dated April 26, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; 6,216 tubes were distributed; firm estimates 2,000 tubes remain on the market. Reason: Product does not meet specifications for the propylparaben ingredient.