FDA RECALLS & COURT ACTIONS: Dec. 8, 1993

Executive Summary

CLASS II -- HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS 5 mg/500 mg, in bottles of 100, 500 and 1,000, for the relief of pain, under the following labels: Blue Cross, Schein Pharmaceuticals, Aligen Independent Laboratories, Goldline, Qualitest, Mason, Moore, IDE Star, URL, Par-Med, Major Pharmaceuticals and Halsey Drug. Recall number: D-046-4. All lots, sizes and labels. Manufacturer: Halsey Drug Company, Inc., Brooklyn, New York. Recalled by: Manufacturer, by letter Nov. 10, 1993. Firm- initiated recall ongoing. Distribution: Nationwide; approximately 450 batches of 1,000,000 tablets each were distributed in the last 3 years. Reason: Abbreviated New Drug Application discrepancies. CLASS III -- GUAIFENESIN AND CODEINE PHOSPHATE SYRUP COUGH PREPARATIONS Tusscidin AC Expectorant Cough Suppressant, 4-fluid ounces and 8- fluid ounces; Tusscidin AC Expectorant Cough Suppressant, 128-fluid ounces; Guiatuss AC Syrup, cough suppressant expectorant, 4-fluid ounces, 1 pint and 1 gallon, manufactured for Goldline Laboratories; Guaifenesin A.C. Syrup, 1 pint (473 ml), manufactured for United Research Laboratories, Inc. Recall number: D-037-4. All lots and codes manufactured between Sept. 25, 1993 and Oct. 13, 1993. Manufacturer: H. R. Cenci Laboratories, Inc., Fresno, California. Recalled by: Manufacturer, by letter October 1993. Firm-initiated field correction complete. Distribution: California, Hawaii, Florida, New Jersey, Ohio, Oregon, Pennsylvania, Texas; firm estimates that about 10,000 units covering all sizes remain on the market. Reason: Product does not meet USP specifications for pH. CLASS III -- SPS SUSPENSION (SODIUM POLYSTYRENE SULFONATE SUSPENSION USP) 473 ml, 120 ml and 60 ml. Recall number: D-036-4. Lot numbers: 473 ml - lots - 192271, 292241, 492101, 692111, 792311, 1092081, 1292011, 193221, 293151, 393161, 593061, 693171, 893191, 993031, 120 ml - lots 492031, 1092271, 993271; 60 ml - lots 192081, 192151, 292123, 392131, 592081, 792141, 892133, 992171, 1092291, 1292031, 193112, 293191, 393101, 493291, 693031, 793291, 893301. Manufacturer: Carolina Medical Products Company, Farmville, North Carolina. Recalled by: Manufacturer, by letters sent the week of Nov. 8, 1993, followed by telephone. Firm-initiated recall ongoing. Distribution: Nationwide; 1,500 473-ml bottles; 200 120-ml bottles; 21,000 60-ml units were distributed. Reason: Use of non-approved formulation. CLASS III -- TRIFLUOPERAZINE HYDROCHLORIDE CONCENTRATE 10 mg/ml, in 2-fluid ounce containers, indicated for the management of manifestations of psychotic disorders as well as the short term treatment of non-psychotic anxiety, where it is considered second- line therapy. Recall number: D-038-4. Lot number 73416. Manufacturer: Geneva Pharmaceuticals, Inc., Broomfield, Colorado. Recalled by: Manufacturer, by letter Nov. 22,1993. Firm-initiated recall ongoing. Distribution: Nationwide; 10,023 units were distributed. Reason: Product does not meet stability specifications. UPDATE: Percodan Tablets Recall #D-029-4, which appeared in the Nov. 24, 1993 "Enforcement Report" ["The Pink Sheet" Nov. 29, T&G-15] should read: Lot #EEA- 001A.