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FDA RECALLS & COURT ACTIONS: April 7, 1993

Executive Summary

CLASS II - DILANTIN KAPSEALS (EXTENDED PHENYTOIN SODIUM CAPSULES, USP) 100 mg, in bottles of 1000, for control of seizures. Recall number: D-191-3. Lot numbers: 01021 FA, 03691 FA, 03891 FA. Manufacturer: Warner-Lambert, Inc., Fajardo, Puerto Rico. Recalled by: Parke Davis, Division of Warner-Lambert Company, Morris Plains, New Jersey, by letter Feb. 12, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; 12,105 units were distributed. Reason: Product does not met dissolution specifications. CLASS II - FUROSEMIDE TABLETS USP 80 mg, packaged in 10 tablet blister packs, a diuretic. Recall number: D-200-3. Lot number 911394 EXP 11/1/93. Manufacturer: Roxane Laboratories, Inc., Columbus, Ohio. Recalled by: Manufacturer, by letter March 24, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; 9,640 cartons of 10 blister packs were distributed. Reason: Product does not meet dissolution specifications. CLASS II - UROCIT-K POTASSIUM CITRATE In bottles of 100, a Rx drug for the prevention of nephrolithiasis (kidney stone formation). Recall number: D-201-3. Lot number 230795 EXP0795. Manufacturer: Mission Pharmacal Company, San Antonio, Texas. Recalled by: Manufacturer, by telephone Feb. 22, 1993, followed by visit, and by letter March 19, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; 5,867 bottles were distributed; firm estimates none remains on the market. Reason: Product does not meet dissolution specifications. CLASS III - RX ORAL COUGH/COLD LIQUIDS (a) Promethazine VC Plain Syrup (Promethazine Hydrochloride 6.25 mg/5 ml & Phenylephrine Hydrochloride 5 mg/5 ml), for the temporary relief of upper respiratory symptoms including nasal, packaged under the following labels: (i) PBI, Manufactured by Pharmaceutical Basics, Inc., in 4 fluid ounce bottles, in 1 pint bottles, and in 1 gallon bottles; (ii) GG, distributed by Geneva Pharmaceuticals, Inc., manufactured by Pharmaceutical Basics, Inc., in 4 fluid ounce bottles and 1 pint bottles; (iii) Major, manufactured by: Pharmaceutical Basics, Inc., for Major Pharmaceuticals Corp., (distributor), in 4 fluid ounce bottles, 1 pint bottles, and in 1 gallon bottles; (iv) Rugby, manufactured for Rugby Laboratories, Inc., manufactured by Pharmaceutical Basics, Inc., in 4 fluid ounce bottles, 1 pint bottles and in 1 gallon bottles; (b) Promethazine with Dextromethorphan Cough Syrup (Promethazine Hydrochloride 6.25 mg/5 ml & Dextromethorphan Hydrobromide 15 mg/5 ml), for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold, packaged in 1 pint bottles under the following labels: (i) PBI, manufactured by Pharmaceutical Basics, Inc., (ii) GG Promethazine DM Cough Syrup, distributed by Geneva Pharmaceuticals, Inc., manufactured by Pharmaceutical Basics, Inc. (iii) Major, manufactured by: Pharmaceutical Basics, Inc., for Major Pharmaceuticals Corp. (distributor); (iv) Rugby Promethazine DM Cough Syrup, manufactured for Rugby Laboratories, Inc., manufactured by Pharmaceutical Basics, Inc. Recall number: D-198/199-3. (a) Lot number 19275, EXP 07/93; (b) lot number 19265, EXP 07/93. Manufacturer: Pharmaceutical Basics, Inc., Morton Grove, Illinois. Recalled by: Manufacturer, by letter March 23, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; (a) 8,640 4-ounce, 20,712 16-ounce, and 384 1-gallon bottles; (b) 15,295 16-ounce bottles were distributed. Reason: Products are subpotent for the promethazine ingredient. CLASS III - SINUBID EXTENDED RELEASE TABLETS In bottles of 100, a Rx analgesic/decongestant/antihistamine. Recall number: D-190-3. Lot numbers: 236DOD EXP 12/93, 27821D EXP 3/94, 40471D EXP 7/94. Manufacturer: Parke-Davis Division, Warner- Lambert Company, Morris Plains, New Jersey. Recalled by: Manufacturer, by letter Nov. 6, 1992. Firm-initiated recall complete. Distribution: Nationwide and Puerto Rico; 8,616 bottles of lot 236DOD, 8,997 bottles of lot 27821D, and 8,935 bottles of lot 40471D were distributed. Reason: Product does not meet dissolution specifications through expiration date.
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