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FDA RECALLS & COURT ACTIONS: Nov. 11 & 18, 1992

Executive Summary

CLASS II -- BRETHAIRE Rx bronchodilator aerosol for oral inhalation: (a) Brethaire -- Terbutaline Sulfate Inhalation Aerosol Inhaler, 0.2 mg each metered dose, 7.5 ml (10.5 g). 300 metered inhalations. Packaged as cartoned canister with mouthpiece. (b) Brethaire -- Terbutaline Sulfate Inhalation Aerosol, 0.2 mg each metered dose. Refill canister for inhaler 7.5 ml (10.5 g). 300 metered inhalations. Packaged as a cartoned canister refill. Recall number: D-055/056-3. Lot numbers: 1911210 EXP OCT 93, 2911210 EXP OCT 93, 3911210 EXP OCT 93. Manufacturer: Riker Laboratories, Inc., Northridge, California. Recalled by: Ciba-Geigy Corporation, Summit, New Jersey, by letter Aug. 21, 1992. Firm-initiated recall ongoing. Distribution: Nationwide; approximately 96,500 canisters were distributed. Reason: Reports of coughing, throat irritation and reduced efficacy. CLASS II -- FLUORESCEIN SODIUM INJ. In glass ampules, used intravenously as a diagnostic aid: (a) 10% Solution; (b) 25% Solution. Recall number: D-052/053-3. Lot numbers and EXP dates: (a) 19221 3/93, 19294 4/93, 19339 6/93, 19377 6/93; (b) 19173 4/93, 19222 3/93, 19273 2/93, 19347 6/93. Manufacturer: Walnut Pharmaceuticals, Inc., Los Angeles, California. Recalled by: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana (formerly Anaheim, California), by letter April 21, 1992. Firm-initiated recall ongoing. Distribution: Louisiana, Oklahoma, Canada; (a) 63,593 units; (b) 54,479 units were distributed. Reason: Presence of small quantities of mercury. CLASS II -- FLUORESCEIN SODIUM, USP Bulk, in 25 kg, 1 kg, and 100 gram bottles. Recall number: D-051-3. Lot numbers: FJ116 and GB096. Manufacturer: Dysers S. A. L., Segovia, Spain. Recalled by: Spectrum Chemical Mfg. Corporation, Gardena, California, by letter April 17, 1992. Firm-initiated recall ongoing. Distribution: Illinois, New Jersey, California, New York, Ohio, Colorado, Washington state; 334.21 pounds were distributed. Reason: Presence of small quantities of mercury. CLASS II -- NIFEDIPINE SOFTGEL CAPSULES, USP (a) 10 mg; (b) 20 mg, in bottles of 100, 300, Rx drug used for vasospastic angina and chronic stable angina, under the following labels: Chase, H.L. Moore Drug Exchange, Martec, Qualitest, Rugby, Lemmon, United Research Laboratories, Warner Chilcott, Genetco, Major, Goldline, Geneva Generics, Best Generics, Schein, Bioline. Recall number: D-065/066-3. (a) All lots with an expiration date prior to and including April 1993, plus nine additional lots: 512119 EXP 5/93, 512219 EXP 5/93, 512319 EXP 5/93, 512419 EXP 5/93, 512519 EXP 5/93, 513019 EXP 5/93, 561819 EXP 5/93, 562419 EXP 5/93, 563319 6/93; (b) Lot numbers: 493819, 517419, 505719, 517519, 505819, 517619, 505919. Manufacturer: Chase Laboratories, Inc., Newark, New Jersey. Recalled by: Manufacturer, by letter dated Sept. 14, 1992, and by telephone. Firm-initiated recall ongoing. Distribution: Nationwide; firm estimates: (a) 3 million capsules remain on the market; (b) none remains on the market. Reason: Lack of assurance to meet compendial dissolution requirements. CLASS II -- PAPAVERINE-PHENTOLAMINE-PROSTOGLANDIN-E1 INJECTABLE DRUG PRODUCT Sold as four 1-cc vials or a single 4-cc vial, a Rx injectable. Recall number: D-054-3. No lot and or serial number was assigned. A six month expiration date was handwritten on each computer-generated label following the manufacture of product (4 cc-vial or 4 1-cc vials). Manufacturer: Catawba Medical Associates Chartered, Mays Landing, New Jersey. Recalled by: Manufacturer, by letter mailed on or about Sept. 14, 1992. Firm-initiated recall ongoing. Distribution: Nationwide; 100 4-cc units were distributed. Reason: Product was marketed without new drug approval and with current good manufacturing practice deficiencies. CLASS II -- Rx LIQUID BRONCHODILATORS Used for the treatment of symptoms of asthma: (a) PBI Oxtriphylline Pediatric Syrup, 50 mg/5 ml, in 16 fluid ounce amber plastic bottles; (b) Theophylline and Guaifenesin Liquid, in 16 fluid ounce amber plastic bottles, packaged under the following labels: PBI Theocolate Liquid; Theolate liquid; Q.B. Liquid. Recall number: D-063/064-3. Lot numbers: (a) 18970, 19302; (b) 18895, 19374. Manufacturer: Pharmaceutical Basics, Inc., Morton Grove, Illinois. Recalled by: Manufacturer, by letter dated Oct. 30, 1992. Firm-initiated recall ongoing. Distribution: Tennessee, New York, Michigan, Puerto Rico, Virginia, North Carolina, Illinois, Kentucky, Connecticut, Pennsylvania, California, Florida, Alabama, New Jersey, Missouri, South Dakota, Ohio, Indiana, Mississippi; firm estimates (a) 50 bottles; (b) 350 bottles remain on the market. Reason: Preservative system not effective through expiration date. CLASS II -- VARIOUS Rx INJECTABLE DRUG PRODUCTS Manufactured by Lyphomed Div. of Fujisawa USA, Inc.: (a) Aminophylline Injection, USP, 25 mg/ml; for the relief of acute bronchial asthma, 10 ml vial, 20 ml vial; (b) Bacteriostatic Sodium Chloride Injection, USP, 0.9%, 10 ml vial, 30 ml vial; (c) Diazoxide Injection, USP, 15 mg/ml, for use in severe hypertension, 20 ml vial; (d) Kanamycin Sulfate Injection, USP, equivalent to 500 mg/2 ml, an antibiotic, 2 ml single dose vial; (e) Kanamycin Sulfate Injection, USP, equivalent to 1 g/3 ml, an antibiotic, 3 ml single dose vial; (f) Kanamycin Sulfate Injection, USP, Pediatric, equivalent to 75 mg/2 ml, an antibiotic, 2 ml single dose vial. Recall number: D- 057/062-3. All lots within expiration date. Manufacturer: Fujisawa USA, Inc., Melrose Park, Illinois; and Fujisawa USA, Inc., Grand Island, New York. Recalled by: Fujisawa USA, Inc., Melrose Park, Illinois, by letter Oct. 29, 1992. Firm-initiated recall ongoing. Distribution: Nationwide, Bahamas, Nigeria, Nicaragua, Hong Kong, Canada, Peru, Belize; firm estimates: (a) 341,715 vials; (b) 215,306 vials; (c) 3,554 vials; (d) 27,645 vials; (e) 126,942 vials; (f) 1,816 vials remain on the market. Reason: Abbreviated new drug application discrepancies. CLASS II -- UPDATES: Recall number: D-234/D-235-2, manufactured by Lyphomed, Division of Fujisawa USA, Inc., which appeared in the March 4, 1992 "Enforcement Report" ("The Pink Sheet" March 9, T&G-10) has been extended as follows: (a) Lyphomed Sodium Chloride Injection, USP, Concentrated 23.4%, 4 mEq/ml, Must Be Diluted Prior to IV Administration, Preservative Free; 30 ml. single dose vial, recall extended to include lot number 311378. Recall number: D-503/518-2, manufactured by Lyphomed, Division of Fujisawa USA, Inc., which appeared in the Sept. 16, 1992 "Enforcement Report" ("The Pink Sheet" Sept. 28, T&G-16) has been extended as follows: Recall number: D-505-2: Cyanocobalamin Injection, USP, 1,000 mcg/ml; 1 ml vials, has been extended to include lot 320053. Various Rx injectables, Recall number: D-024/041-3, manufactured by Lyphomed, Division of Fujisawa USA, Inc., which appeared in the Oct. 28, 1992 "Enforcement Report" has been extended as follows: Recall number: D-028-3, Calcium Gluconate Injection, USP, 10%, has been extended to include 50 ml vial, lot numbers 301065, 301067. Recall number: D-029-3, Lidocaine HCl Injection, USP, 4% (40 mg/ml), has been extended to include lot number 300735. Recall number: D-030-3, Lidocaine HCl Injection, USP, 2% (20 mg/ml), has been extended to include 20 ml vials, and 30 ml vials, lot numbers 310980, 310763. Recall number: D-032-3, Mannitol Injection, USP, 25%, has been extended to include lot numbers 300006, 300284, 300285, 300414, 300416, 310204, 310967, 320009, 320272. Recall number: D-034-3, Sodium Chloride Injection, USP Concentrated, 23.4%, has been extended to include lot numbers 300945, 300946, 301062, 301381, 301382, 310066, 310481. Recall number: D-035-3: Sodium Chloride Injection, USP, 0.9%, has been extended to include 2 ml vials, lot numbers 300823, 300824, 300826, 301086, 301087, 301088, 301424, 310358, 310359, 310360, 310374, 310377, 310511, 310514, 320604, 320720. Recall number: D-037-3, Sterile Water for Injection, USP, has been extended to include 5 ml glass, lot number 311174; 50 ml glass, lot numbers 300953, 301458, 310310; 100 ml glass, lot numbers 300959, 300962, 310209. Recall number: D-041-3, Dextrose Injection, USP, 50%, has been extended to include lot number 301154.
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