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FDA RECALLS & COURT ACTIONS: April 14, 1993

Executive Summary

CLASS II - DELFLEX BRAND PERITONEAL DIALYSIS SOLUTION, USP 2.5% dextrose, 2,000 ml, an Rx drug used for the treatment of problems associated with kidney disorders. Recall number: D-205-3. Lot number 07-067-2K EXP 4/94. Manufacturer: Fresenius USA, Inc., Ogden, Utah. Recalled by: Fresenius USA, Inc., Walnut Creek, California, by telephone March 10, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; 742 bags were distributed. Reason: Some labels incorrectly declared dextrose content as 1.5% instead of 2.5%. CLASS II - (a) DIAZEPAM INJECTION, USP, 5 MG/ML; (b) CYANOCOBALAMIN INJECTION, 1,000 MCG/ML (a) In 10 ml amber glass vials, Rx, for intravenous or intramuscular use; (b) in 10 ml amber glass vials, Rx, for intramuscular or deep subcutaneous use. Recall number: D-208/209-3. Lot numbers: (a) 92D640, 92G910, 92H410; (b) 92A590, 92F840. Manufacturer: Steris Laboratories, Inc., Phoenix, Arizona. Recalled by: Manufacturer, by telephone February 19, 1992, followed by letter February 26, 1993. Firm-initiated field correction ongoing. Distribution: Nationwide; (a) 3,970 units; (b) 4,511 vials were distributed. Reason: Some correctly labeled vials of each product may be found in unit cartons labeled as the other product. CLASS II - (a) NITROUS OXIDE CYLINDERS; (b) CARBON DIOXIDE CYLINDERS Both size E. Recall number: D-212/213-3. Lot numbers: (a) LMB 093G EXP 2/98; (b) LMB 093A EXP 2/98. Manufacturer: Liquid Carbonic Specialty Gas Corporation, Lemoyne, Pennsylvania. Recalled by: Manufacturer, by telephone February 24, 1993. Firm-initiated recall complete. Distribution: Pennsylvania; 16 cylinders were distributed; firm estimates none remains on the market. Reason: Cylinders were overfilled. CLASS III - ATROVENT (IFRATROPIUM BROMIDE) INHALATION AEROSOL Supplied as a metered dose inhaler in a pressurized aerosol canister, an Rx bronchodilator. Recall number: D-211-3. Lot number 920632A. Manufacturer: 3M Health Care Specialties Division, St. Paul, Minnesota. Recalled by: Boehringer Ingleheim Pharmaceuticals, Inc., Ridgefield, Connecticut, by letter February 11, 1993. Firm- initiated field correction complete. Distribution: Nationwide; 75,155 canisters were distributed; firm estimates none remains on the market. Reason: Shrink wrap label incorrectly declares expiration date of 4/92 instead of 4/94. CLASS III - CEPHALEXIN FOR ORAL SUSPENSION, USP 125 mg/5 ml and 250 mg/5 ml strengths; packaged in 100 ml and 200 ml bottles, an Rx oral semisynthetic cephalosporin antibiotic for the treatment of infections when caused by susceptible strains of Streptococcus and Staphylococcus microorganisms, distributed under the following labels: (a) 125 mg/5 ml -- (i) Novopharm, manufactured for Novopharm Inc., Schaumburg, Illinois, 100 ml; (ii) Aligen, distributed by Aligen Independent Laboratories, Inc., Jackson, Wyoming, 100 ml and 200 ml; (iii) Biocef, distributed by International Ethical Labs, Inc., Rio Piedras, Puerto Rico, 100 ml; (iv) Danbury, distributed by Danbury Pharmacal Inc., Danbury, Connecticut, 100 ml and 200 ml; (v) GG (Geneva Generics), distributed by Geneva Pharmaceuticals, Inc., Broomfield, Colorado, 100 ml and 200 ml; (vi) Schein, manufactured for Schein Pharmaceutical, Inc., Port Washington, New York, 100 ml and 200 ml; (vii) Seyer, distributed by Seyer Pharmacal, San Juan, Puerto Rico, 100 ml; (viii) URL, distributed by United Research Laboratories, Inc., Bensalem, Pennsylvania, 100 ml and 200 ml; (b) 250 mg/5 ml - (i) Novopharm, manufactured for Novopharm Inc., Schaumburg, Illinois, 100 ml; (ii) Genetco, distributed by Genetco Inc., RonKonKoma, New York, 100 ml; (iii) GG (Geneva Generics), distributed by Geneva Pharmaceuticals, Inc., Broomfield, Colorado, 100 ml, (iv) Schein, manufactured for Schein Pharmaceutical, Inc., Port Washington, New York, 100 ml and 200 ml; (v) URL, distributed by United Research Laboratories, Inc., Bensalem, Pennsylvania, 100 ml and 200 ml. Recall number: D-206/207-3. Code: (a) 100 ml: 1500140, 1500240, 1597340, 1597440; 200 ml: 1500153, 1595453, 1597453; (b) 100 ml: 0791240, 0791340, 0791440; 200 ml: 0791253. Manufacturer: Novopharm Ltd., Scarborough, Ontario, Canada. Recalled by: Novopharm Inc., Schaumburg, Illinois (distributor), by letters dated March 29, 1993. Firm-initiated recall ongoing. Distribution: Nationwide, Puerto Rico; (a) 20,059 100-ml and 4,193 200-ml bottles; (b) 17,506 100-ml bottles and 2,181 200-ml bottles were distributed; firm estimates little, if any, remains on the market. Reason: Sodium benzoate preservative found below ANDA specification. CLASS III - DICYCLOMINE HCL TABLETS, USP, 20 MG Used for the treatment of functional bowel/irritable bowel syndrome, and for relieving smooth muscle spasms of the gastrointestinal tract. Recall number: D-203-3. Lot numbers: 1516-009 EXP 7/93, 1516-010 EXP 7/93. Manufacturer: Barr Laboratories, Pomona, New York. Recalled by: Vangard Labs, Inc., Glasgow, Kentucky, by letter dated March 17, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; 1,125 boxes of 100 blister packs were distributed. Reason: Small degree of superpotency.
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