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FDA RECALLS & COURT ACTIONS: March 10, 1993

Executive Summary

CLASS II - DEY-LUTE ISOETHARINE INHALATION SOLUTION, USP 0.08% S/F, 3 ml, a Rx drug used for the treatment of asthma. Recall number: D-165-3. Lot number 2297 EXP 5/94. Manufacturer: Dey Laboratories, Inc., Napa, California. Recalled by: Manufacturer, by telephone followed by letter, January 20, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; 3,455 shelf cartons were distributed. Reason: Some shelf cartons are mislabeled as 0.25%. The vials are correctly labeled. CLASS II - NITROUS OXIDE, USP A Rx medicinal gas used for anesthesia, in G cylinders. Recall number: D-166-3. Lot number 611A315 (on paper tag), label code MG816C. Manufacturer: BOC Group/Airco Medical Specialty Gases, Carol Stream, Illinois. Recalled by: BOC Group/Airco Gases, Murray Hill, New Jersey, by telephone February 18, 1993, followed by letter February 19, 1993. Firm-initiated recall ongoing. Distribution: Illinois, Indiana, Iowa, Wisconsin; 60 cylinders were distributed, with 52 accounted for. Reason: Potential overfilled cylinders. CLASS II - PROMETHAZINE SYRUP PLAIN In 1 pint bottles, used for perennial and seasonal allergic rhinitis. Recall number: D-163-3. Lot number 082543 EXP 7/94. Manufacturer: H.R. Cenci Laboratories, Inc, Fresno, California, by letter October 22, 1992. Firm-initiated recall complete. Distribution: New York, Oregon, Michigan, Ohio, Puerto Rico; 500 mislabeled bottles were distributed. Reason: Some bottles were mislabeled as Promethazine VC Syrup Plain which would contain phenylephrine HCI as an ingredient. CLASS II - SOLOPAK HYDRALAZINE HCL INJECTION USP 20 mg/ml; 1 ml single dose vial, 25 vials per case, a Rx intramuscular/intravenous antihypertensive. Recall number: D-169-3. Lot numbers: 910826, 910926, 911120, 911251, 920124, 920202, 920242, 920316, 920445, 920455, 920524, 920947, 921130, 921229. Manufacturer: SoloPak Pharmaceuticals, Inc., Elk Grove Village, Illinois. Recalled by: Manufacturer, by letters dated February 22, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; 1,285,350 vials were distributed; firm estimates that 15% of the product remains on the market. Reason: Possible presence of particulate matter. SEIZURE - POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS (92-579-219) Charge: New drug - There is no approved application in effect for this article since it was produced under conditions significantly different than those approved in the application. Firm: Parmed Pharmaceuticals, Niagara Falls, New York. Filed: February 22, 1993; U.S. District Court for the Western District of New York; Civil number 93-CV-0152A, FDC number 66655. Seized: March 1, 1993 - goods valued at approximately $18,800.
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