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FDA RECALLS & COURT ACTIONS: August 11, 1993

Executive Summary

CLASS II -- AMOXICILLIN CHEWABLE TABLETS, USP, 250 MG In bottles of 100, Rx antibiotic, under the following labels: Qualitest, Major, Goldline, Rugby, Biocraft. Recall number: D-305-3. Lot number 31144 EXP 11/1/94. Manufacturer: Biocraft Laboratories, Inc., Elmwood Park, New Jersey. Recalled by: Biocraft Laboratories, Inc., Fair Lawn, New Jersey, by telephone April 26 & 27, 1993. Firm-initiated recall complete. Distribution: Alabama, California, Florida, Illinois, Kentucky, Michigan, New York, Rhode Island; 6,139 bottles were distributed. Reason: Use of unapproved manufacturing procedures. CLASS II -- HYDROCORTISONE 1% AND ACETIC ACID 2% OTIC SOLUTION USP 10 ml bottle, Rx for the treatment of superficial infections of the external auditory canal, under the following labels: Genetco, Qualitest, Beta Dermaceuticals, H. L. Moore, Aligen, Major, C.O., Truxton, IDE, Rugby, Geneva, Goldline, Schein, Harber, URL, UDL. Recall number: D-307-3. All lot numbers. Manufacturer: Thames Pharmacal Company, Inc., Ronkonkoma, New York. Recalled by: Manufacturer, by telephone July 19-21, 1993, followed by letter July 22, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; Firm estimates 15,000 bottles remain on the market. Reason: Subpotency of the acetic acid ingredient. CLASS II -- TECHNETIUM TC-99M GENERATOR Diagnostic imaging agent. Recall number: D-308-3. Lot number 9249- 5F-333. Manufacturer: The DuPont Merck Pharmaceutical Company, Radiopharmaceutical Division, No. Billerica, Massachusetts. Recalled by: Manufacturer, by telephone and by letter December 14, 1992. Firm-initiated recall complete. Distribution: Missouri; 1 unit was distributed. Reason: Non-sterility. CLASS III -- PHENAZOPYRIDINE HCL TABLETS USP, 200 mg under the Rugby label, under Qualitest and TTC Trinity labels; Pyridiate Tablets, 200 mg, under the Rugby label, for symptomatic relief of pain, burning, urgency, frequency and other discomforts arising from irritation of the lower urinary tract mucosa. Recall number: D-311-3. Lot number D132D. Manufacturer: Trinity Technologies Corporation, Roseville, Michigan. Recalled by: Manufacturer, by telephone May 28, 1993. Firm-initiated recall complete. Distribution: Alabama, New York; 600 1,000-tablet bottles were distributed. Reason: Short fill. CLASS III -- PROP-A-HIST ANTIHISTAMINE-DECONGESTANT CAPLETS In 100 tablet bottles, for symptomatic relief of rhinitis, allergic bronchitis, bronchospasm, hay fever, common cold, sinusitis and skin allergies. Recall number: D-312-3. Lot number K116C EXP 10/96. Manufacturer: Trinity Technologies Corporation, Roseville, Michigan. Recalled by: Manufacturer, by telephone December 21, 1992. Firm- initiated recall complete. Distribution: Texas; 1,000 100-tablet bottles were distributed. Reason: Stability data does not support expiration date. CLASS III -- THIOPENTAL SODIUM FOR INJECTION 400 mg and 500 mg strengths, in 200 ml vials, for use as induction anesthetic. Recall number: D-309/310-3. All lots. Manufacturer: International Medication Systems, Ltd., South El Monte, California. Recalled by: Manufacturer, by letter July 6, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; 19,149 units of stock number 5040 and 544,839 units of stock number 5050 were distributed. Reason: Product may form a precipitate after reconstitution. CLASS III -- THIOTHIXENE HCL ORAL SOLUTION USP, concentrate, in 30 ml and 120 ml bottles, used in the management of psychotic disorders, under the Barre and Goldline labels. Recall number: D-306-3. Lot 03909 EXP 1/93 and 13461 EXP 9/93. Manufacturer: Barre-National, Inc., Baltimore, Maryland. Recalled by: Manufacturer, by letter October 29, 1992. Firm- initiated recall ongoing. Distribution: Nationwide; 25,948 bottles were distributed. Reason: Product below specification for alcohol content.

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