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FDA RECALLS & COURT ACTIONS: Oct. 13 & 20, 1993

Executive Summary

CLASS I -- ADRUCIL 100 ml vials, an anti-neoplastic, anti-metabolic infusion drug. Recall number D-007-4. Adria lot number FFC015; Abbott lot number 75004T4. Manufacturer: Adria-SP,Inc., Albuquerque, New Mexico. Recalled by: Adria Laboratories, Columbus, Ohio, by telephone Sept. 17 and 20, 1993, and by letter Sept. 29, 1993. Firm-initiated recall ongoing. Distribution: Nationwide and Canada; 4,150 vials. Reason: Non-sterility. CLASS II -- ALBUTEROL SULFATE INHALATION SOLUTION 0.5%, Rx oral inhalation drug used for the relief of bronchospasm, in 0.25 ml plastic unit dose tubes. Recall number: D-006-4. Lot number E003 EXP November 1993. Manufacturer: Xactdose, Inc., South Beloit, Illinois (repacker). Recalled by: Repacker, by letters dated Sept. 29, 1993. Firm-initiated recall ongoing. Distribution: California, Texas, Illinois, Ohio, Pennsylvania, Florida; 159 cases (120 tubes per case). Reason: The lot failed uniformity of dosage testing. CLASS II -- BANCAP HC CAPSULES In 100 and 500 capsule bottles, Rx, for the relief of moderate to moderately severe pain. Recall number: D-004-4. Lot numbers: 89022 EXP November 1993, 89023 EXP November 1993, 2914 EXP March 1994,2915 EXP March 1994, 5916 EXP June 1994, 5917 EXP June 1994, 5918 EXP June 1994 (100's); 4917 EXP June 1994, 5918 EXP June 1994 (500's). Manufacturer: Forest Pharmaceuticals, Inc., Cincinnati, Ohio. Recalled by: Forest Pharmaceuticals, Inc., St. Louis, Missouri, by letter Sept. 24, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; 38,984 bottles. Reason: Unreliable data in the Abbreviated New Drug Application. CLASS II -- CROMOLYN SODIUM INHALATION, USP In 2 ml plastic tubes, Rx aqueous solution for nebulization for the management of patients with bronchial asthma. Recall number: D-002-4. Lot number A001 through A037, all expiration dates. Manufacturer: Xactdose, Inc., South Beloit, Illinois (repacker). Recalled by: Repacker, by letter Sept. 24, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; 2,387 cases (120 tubes per case) were distributed; firm estimates little product, if any, remains on the market. Reason: Current good manufacturing practice and labeling deficiencies. CLASS II -- ESGIC TABLETS In 100 tablet and 500 tablet bottles, Rx for the temporary relief of the symptom complex of tension headache. Recall number: D-003-4. Lot numbers: 9912 EXP 10/93 (100-tablet), 10917 EXP 11/93 (500-tablet). Manufacturer: Forest Pharmaceuticals, Inc., Cincinnati, Ohio. Recalled by: Forest Pharmaceuticals, Inc., St. Louis, Missouri, by letter Sept. 1, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; 14,625 bottles of lot 9912 and 2,888 bottles of lot 10917 were distributed. Reason: Unreliable data in the Abbreviated New Drug Application. FDA UPDATE -- Epi Pen, 0.3 mg Epinephrine Auto-Injector, Recall number: D-332-3, which appeared in the Sept. 8 "Enforcement Report" as a Class III should have appeared as a Class II recall ("The Pink Sheet" Sept. 13, T&G-14). CLASS III -- BISACODYL LAXATIVE SUPPOSITORIES In boxes of 12, each labeled to contain 10 mg Bisacodyl USP. Recall number: D-001-4. Lot number 90921 EXP 11/95. Manufacturer: Great Southern Laboratories (GSL), Houston, Texas. Recalled by: Manufacturer, by letter Dec. 29, 1992. Firm-initiated recall complete. Distribution: Alabama, California, Florida, Iowa, Illinois, Louisiana, Maryland, Michigan, Mississippi, New Jersey, New York, Texas; 11,325 boxes (12 units per box) were dostrobited. Reason: Subpotency.
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