FDA RECALLS & COURT ACTIONS: August 18, 1993

Executive Summary

CLASS II -- DIAZEPAM, TABLETS 2 mg, in bottles of 100, used for anxiety disorders,. Recall number: D-318-3. Lot numbers: 1532-040, 1532-041. Manufacturer: Lederle Laboratories, Inc., Pearl River, New York. Recalled by: Vanguard Labs, Inc., Glasgow, Kentucky (repacker), by letter July 30, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; 535 boxes were distributed. Reason: A bottle received from the manufacturer labeled as containing 2 mg tablets contained 5 mg tablets. CLASS III -- ACETAMINOPHEN WITH CODEINE TABLETS 300 mg, in 100 tablet unit dose cartons, 5 sheets of 20 unit dose blister packs, and 10 sheets of 10 unit dose blister packs, Rx drug for the relief of mild to moderately severe pain. Recall number: D-313-3. Lot numbers 2F747. Manufacturer: Barr Laboratories, Inc., Northvale, New Jersey. Recalled by: UDL Laboratories, Inc., Rockford Illinois (repacker), by telephone July 9-28, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; 347 unit cartons were distributed; firm estimates 28 cartons remain on the market. Reason: Potency of codeine ingredient not assured through expiration date. CLASS III -- CONEX PLUS TABLETS, ANTIHISTAMINIC/ANALGESIC/ DECONGESTANT In bottles of 1,000, for the temporary symptomatic relief of nasal congestion, mild pain, and fever. Recall number: D-317-2. Lot number 29129 EXP 4/94. Manufacturer: Forest Pharmaceuticals, Inc., Cincinnati, Ohio. Recalled by: Forest Pharmaceuticals, Inc., St. Louis, Missouri, by telephone April 30, 1993. Firm-initiated recall complete. Distribution: Indiana, Pennsylvania, Kentucky, Maine, Tennessee, Iowa, Illinois, New Jersey, Alabama, Arizona, Michigan, Ohio, Missouri; 234 bottles were distributed. Reason: Subpotency of the phenylpropanolamine ingredient. CLASS III -- CONEX D.A., DECONGESTANT/ANTIHISTAMINIC In bottles of 100 and 1,000, for temporary relief of symptoms associated with nasal allergies, sinusitis and rhinitis. Recall number: D-315-3. Lot 10901 EXP 11/93. Manufacturer: Forest Pharmaceuticals, Inc., Cincinnati, Ohio. Recalled by: Forest Pharmaceuticals, Inc., St. Louis, Missouri, by telephone April 30, 1993. Firm-initiated recall complete. Distribution: Nationwide; 1,147 100-tablet bottles and 230 1,000-tablet bottles were distributed. Reason: Subpotency of the phenylpropanolamine ingredient. CLASS III -- QUELTUSS ANTITUSSIVE-EXPECTORANT Packaged in 1,000-tablet bottles, a non-narcotic cough suppressant. Recall number: D-316-3. Lot number 1912 EXP 3/94. Manufacturer: Forest Pharmaceuticals, Inc., Cincinnati, Ohio. Recalled by: Forest Pharmaceuticals, Inc., St. Louis, Missouri, by telephone April 30, 1993. Firm-initiated recall complete. Distribution: California, Indiana, Wisconsin, Ohio, Minnesota, Colorado, Kentucky, Iowa, New York, Illinois, Canada; 186 bottles were distributed. Reason: Subpotency of the dextromethorphan ingredient. CLASS III -- SULFISOXAZOLE/PHENAZOPYRIDINE HCL 500 mg/50 mg labeled as Azo-Gulfasin, Major label; Sulfisoxazole and Phenazopyridine HCI 500 mg/50 mg, Trinity label; Azo-Sulfisoxazole, Qualitest label, in bottles of 100 and 1,000, for initial treatment of uncomplicated urinary tract infections. Recall number: D-314-3. Lot numbers: C119D, C120D, D121D, D111D, D110D, D124D. Manufacturer: Manufacturing Chemists, Inc., Indianapolis, Indiana. Recalled by: Trinity Technologies Corporation, Roseville, Michigan, by letter July 27, 1993. Firm-initiated recall ongoing. Distribution: Alabama; 60 100-tablet bottles, Lot C119D, (Major label); 1,307 100-tablet bottles, Lot C119D, (Trinity label); 1,097 100-tablet bottles, Lot C120D, (Trinity label); 68 1,000-tablet bottles, Lot D111D, (Major label); 1,247 100-tablet bottles, Lot D110D, (Trinity label); 2,437 100-tablet bottles, Lot C124D, (Qualitest label) were distributed. Reason: Product marketed without new drug approval.