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FDA RECALLS & COURT ACTIONS: March 31, 1993

Executive Summary

CLASS II - BUSPAR (BUSPIRONE HCL) 10 mg tablets, an antianxiety agent, in 100 tablet bottles. Recall number: D-188-3. Lot number HIJ91A EXP 10/94. Manufacturer: Bristol- Myers Squibb, Mayaguez, Puerto Rico. Recalled by: Bristol-Myers Squibb Company, Pharmaceutical Group Technical Operations, New Brunswick, New Jersey, by letter December 10, 1992. Firm-initiated recall ongoing. Distribution: Nationwide; Approximately 29,490 bottles were distributed; firm estimates 15,550 bottles remain on the market. Reason: Some tablets are superpotent. CLASS II - DIPRIVAN (PROPOFOL) INJECTION 10 mg/ml, in single-patient infusion vials, used for intravenous anesthesia. Recall number: D-189-3. Lot numbers: 3049N, 3141N, 3145N, 3210N. Manufacturer: Kabi Pharmacia, Stockholm, Sweden. Recalled by: Zeneca Pharmaceutical Group, Wilmington, Delaware, by fax and telephone on February 25, 1993, followed by letter February 26, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; 14,000 units were distributed; firm estimates 7,300 units remain on the market. Reason: Some vials have a potential for cracks which may result in a lack of assurance of sterility. CLASS II - NYSTATIN TABLETS USP 500,000 units, in bottles of 100, for the treatment of intestinal candidiasis. Recall number: D-182-3. Lot number H733-01 EXP 12/93. Manufacturer: Pharmaceutical Basics, Inc., Denver, Colorado. Recalled by: Manufacturer, by letter March 3, 1993. Firm-initiated recall ongoing. Distribution: Washington state, Louisiana, Minnesota, Alabama, New Mexico, California, Florida, Ohio, Oregon; 1,105 bottles were distributed. Reason: Potency not assured through expiration date. CLASS II - POVIDONE-IODINE 5% SURGICAL SCRUB Packaged in bottles of 16 oz., and one gallon sizes, used as a topical antiseptic under the following labels: Thames, Rugby, IDE, Bioline, Goldline, Schein, Qualitest. Recall number: D-184-3. All lots within their expiration date. Manufacturer: Thames Pharmacal Co. Inc., Ronkonkoma, New York. Recalled by: Manufacturer, by telephone February 3, 1993, followed by letter February 11, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; Approximately 8,000 16-ounce bottles and 1,500 one gallon bottles were distributed. Reason: Potency not assured through expiration date. CLASS II - SULFASALAZINE TABLETS 500 mg, a Rx anti-bacterial, in 500 tablet bottles. Recall number: D-183-3. Lot number 3960-31 EXP 4/94. Manufacturer: Lederle Laboratories, Pearl River, New York. Recalled by: Manufacturer, by letter January 27, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; 1,160 bottles were distributed. Reason: Product does not meet dissolution specification through expiration date. CLASS III - NALFON TABLETS, TABLET number 1900, FENOPROFEN CALCIUM Tablets, USP 600 mg, in bottles of 100 and 500, a Rx drug used for relief of rheumatoid arthritis and osteoarthritis. Recall number: D-181-3. All lots. Manufacturer: Eli Lilly & Company, Indianapolis, Indiana. Recalled by: Manufacturer, by letter December 16, 1992. Firm-initiated recall ongoing. Distribution: Nationwide, The Netherlands, Puerto Rico; 904,192 bottles of 100 tablets and 164,000 bottles of 500 tablets were distributed in the United States including Puerto Rico. 1,268 bottles of 100 were distributed in the Netherlands. Firm-estimates 10,000 bottles of 100 tablets and 700 bottles of 500 remain on the market. Reason: Product does not meet dissolution specifications through expiration date. CLASS III - PHENAZOPYRIDINE HCl 100 mg sugar coated tablets, in bottles of 100, indicated for the symptomatic relief of pain, burning, urgency, frequency and the discomforts arising from irritation of the lower urinary tract mucosa. Recall number: D-180-3. Lot number 11201 which was later changed to AABM. Manufacturer: Manufacturing Chemists, Inc., Indianapolis, Indiana. Recalled by: Manufacturer, by telephone October 26, 1992, followed by letters dated October 26 & 27, 1992. Firm-initiated recall ongoing. Distribution: New Jersey, Florida, New York, Michigan, California; Approximately 800,000 tablets were distributed. Reason: Product does not meet dissolution specifications.
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