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FDA RECALLS & COURT ACTIONS: Aug. 5, 1992

Executive Summary

CLASS II -- CEPHRADINE CAPSULES 250 mg, a semi-synthetic cephalosporin, in 100 capsule bottles, under Barr and Major labels. Recall number: D-438-2. Lot number 01550CZ EXP 9/92 (or 10/92 on some Barr labels). Manufacturer: Barr Laboratories, Inc., Pomona, New York. Recalled by: Manufacturer, by letter July 17, 1992. Firm-initiated recall ongoing. Distribution: Nationwide; 11,457 bottles were distributed. Reason: Subpotency. CLASS II -- VARIOUS Rx INJECTABLE DRUG PRODUCTS (a) Atropine Sulfate Injection, USP, 1 ml, in multiple dose vials, (i) 1 mg/ml, (ii) 0.3 mg/ml; (b) Heparin Sodium Injection, 1,000 USP units/ml, in 1 ml single dose vials; (c) Magnesium Sulfate Injection, USP, 50%, 500 mg/ml; in 2 ml single dose vials. Recall number: D-440/443-2. Lot numbers: (a) 1 mg/ml: lot number 311331 EXP 12/94, 320144 EXP 2/95; 0.3 mg/ml: lot number 320154 EXP 2/94; (b) 320282 EXP 3/94; (c) 320141 EXP 7/93, 320219 EXP 8/93, 320086 EXP 7/93. Manufacturer: Lyphomed, Division of Fujisawa USA, Inc., Grand Island, New York. Recalled by: Lyphomed, Division of Fujisawa USA, Inc., Melrose Park, Illinois, by letter July 16, 1992. Firm- initiated recall ongoing. Distribution: (a & b) Nationwide; (c) Nationwide and Hong Kong; (a) 309,375 vials (1 mg/ml) and 2,925 vials (0.3 mg/ml) of Atropine Sulfate were distributed, with the firm estimating that 87,000 vials of 1 mg and 1,000 vials of 0.3 mg product remain on the market; (b) 123,975 vials were distributed, with the firm estimating that 31,000 vials remain on the market; (c) 492,600 vials were distributed, with the firm estimating that 96,000 vials remain on the market. Reason: The vials have a low fill volume. CLASS II UPDATE -- DISOPYRAMIDE PHOSPHATE CAPSULES Recall number: D-435-2, Disopyramide Phosphate Capsules, 100 mg, which appeared in the July 29, 1992 Enforcement Report ("The Pink Sheet" Aug. 3, T&G17) should read: Recalled by: Barr Pharmaceuticals, Inc., Pomona, New York by letter July 9, 1992. CLASS III -- MMI OPTI-UP BRAND BARIUM SULFATE For suspension for use in air contrast examination of the upper gastrointestinal tract, in 312 gram cups. Recall number: D-444-2. Lot number 904920. Manufacturer: Century Pharmaceutical, Inc., Indianapolis, Indiana. Recalled by: MMI, Inc., Southfield, Michigan, by letter April 7, 1992. Firm-initiated recall complete. Distribution: New Jersey, Michigan, Missouri, Texas, South Carolina, Abu Dhabi UAE, Switzerland; 1,536 cups were distributed; firm estimates none remains on the market. Reason: Incorrect expiration date on product. CLASS III -- NATURLAX Sugar free orange flavored psyllium hydrophilic mucelloid, a natural fiber laxative. Recall number: D-439-2. Lot number 910936. Manufacturer: Cenci Powder Products, Inc., Fresno, California. Recalled by: Manufacturer, by telephone and by letters of Jan. 8 and 27, 1992. Firm-initiated recall ongoing. Distribution: California, Florida, Minnesota, New Jersey, Tennessee; 1,224 bottles distributed. Reason: Sugar free product packed in bottles labeled as containing sugar. CLASS III -- TECHNETIUM Tc 99m GENERATOR Sterile, non-pyrogenic, a diagnostic agent for intravenous injection. Recall number: D-436-2. Lot number 9221-4F-071. Manufacturer: The DuPont Merck Pharmaceutical Company, No. Billerica, Massachusetts. Recalled by: Firm notified of the problem by the consignee on June 1, 1992. Unit was returned to the firm on the same date. Firm-initiated recall complete. Distribution: California; 1 unit was distributed and was destroyed 7/15/92. Reason: Unit received less than intended fill. CLASS III -- VALPIN 50, ANISOTROPINE METHYLBROMIDE 50 mg oral tablets, in 100 tablet bottles, a Rx anticholinergic. Recall number: D-437-2. Lot number DN236A 12/94. Manufacturer: DuPont Pharmaceuticals, Garden City, New York. Recalled by: Manufacturer, by letter June 9, 1992. Firm-initiated recall ongoing. Distribution: Nationwide, Puerto Rico; 6,003 bottles were distributed; firm estimates 2,500 bottles remain on the market. Reason: Product does not meet content uniformity specifications.
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