FDA Recalls & Court Actions: March 14 & 21, 1990
CLASS I -- GOLDLINE BRAND CARISOPRODOL TABLETS 350 mg, in 100 tablet bottles, an Rx oral centrally acting skeletal muscle relaxant. Lot numbers: 824039, 844059, 863069, 882079, 883079, 919099. Manufacturer: Bolar Pharmaceuticals Company, Inc., Copiague, New York. Recalled by: Manufacturer, by letter Feb. 13, 1990. Firm-initiated recall ongoing. Distribution: Goldline Laboratories distribution centers located in Connecticut, Texas, Florida, California, Ohio. Approximately 43,920 bottles were distributed. Reason: A bottle of Goldline brand carisoprodol 350 mg tablets was found mislabeled as Goldline brand doxycycline hyclate 100 mg tablets. CLASS II -- TIMENTIN BRAND OF STERILE TICARCILLIN DISODIUM CLAVULANATE POTASSIUM POWDER FOR RECONSTITUTION 3.1 grams, add-vantage antibiotic vial for interavenous administration. Lot #MM4117 EXP 1/91. Manufacturer: Beecham Laboratories, Piscataway, New Jersey. Recalled by: Beecham Laboratories, Bristol, Tennessee, by letter Feb. 12, 1990. Firm-initiated recall ongoing. Distribution: Illinois, Indiana, Kansas, Michigan, Minnesota, Mississippi, Missouri, Ohio, South Dakota, Wisconsin. 16,970 vials were distributed; firm estimates very few, if any of this lot remains on market. Reason: Lack of assurance of sterility. CLASS III -- BACITRACIN OINTMENT, USP 500 units per gram in 1 ounce tubes an OTC antibiotic for topical application. All lots. Manufacturer: Eli Lilly and Company, Indianapolis, Indiana. Recalled by: Manufacturer, by letters Feb. 13 and 16, 1990. Firm-initiated recall ongoing. Distribution: Nationwide. Firm-estimates 6,000 tubes remain on market. Reason: Stability testing reveals product potency not assured through expiration date. CLASS III -- (a) CHRONULAC; (b) CEPHULAC (a) 30 ml unit dose, 8 ounces and 32 ounces; (b) 30 ml unit dose, 16 ounces and 64 ounces, lactulose syrup USP Rx products used to relieve constipation. All products with an EXP date of 5/91 or earlier. Manufacturer: Merrell Dow Pharmaceuticals, Inc., Cincinnati, Ohio. Recalled by: Manufacturer, by letters dated Feb. 26-27, 1990. Firm-initiated recall ongoing. Distribution: Nationwide. (a) 166,000 trays (30 ml.), 608,000 bottles (8 oz.), 448,000 bottles (32 oz.); (b) 243,000 trays (30 ml.), 768,000 bottles (16 oz.), 108,000 bottles (64 oz) were distributed. (Each tray contains 10/30 ml unit dose containers.) Reason: Some lots are adulterated with penicillium mold. CLASS III -- GRISEOFULVIN ORAL TABLETS 500 mg, an Rx antifungal for systemic use, in bottles of 100 and 500 tablets. Lot numbers (100's) 19D116 EXP 4/94, 19D117 EXP 4/94, 19D118 EXP 4/94, 19D119 EXP 4/94; (500's) 19C114 EXP 3/94, 19D119 EXP 4/94. Manufacturer: Ortho Pharmaceutical Corporation, Raritan, New Jersey. Recalled by: Manufacturer, by letter Nov. 10, 1989. Firm-initiated recall ongoing. Distribution: Nationwide, Puerto Rico. 5,024 bottles of 100 and 622 bottles of 500 were distributed Reason: Presence of surface mold on some tablets. CLASS III -- MAJOR BRAND PSEUDO-GEST PLUS TABLETS In 100 tablet bottles, an OTC immediate release nasal decongestant/antihistamine. Lot numbers: G996701 EXP 7/91, H900001 EXP 9/91. Manufacturer: Private Formulations, Inc., Edison, New Jersey. Recalled by: Manufacturer, by letters Nov. 1, and 22, 1989. Firm-initiated recall ongoing. Distribution: California, Michigan, Washington state. 6,072 bottles were distributed, firm estimates 1,797 remain at the retail level. Reason: Labeling error. Directions for use were omitted from product label. CLASS III -- RUGBY BRAND GUIAPHED ELIXIR 16 ounce bottle, an OTC oral liquid preparation used as a bronchodilator -decongestant. Lot numbers: 92735, 92252. Manufacturer: Barre-National, Inc., Baltimore, Maryland. Recalled by: Manufacturer, by letter Feb. 13, 1990. Firm-initiated recall ongoing. Distribution: New York. 1,368 bottles were distributed. Reason: Labeling error -- Product contains 19 percent alcohol. Alcohol content not declared on label. SEIZURE ACTION FILED -- BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE CAPSULES Charge: Products are unapproved new drugs. Firm: Halsey Drug Company, Inc., Brooklyn, New York. Filed: Feb. 13, 1990 -- U.S. District Court for the Eastern District of New York; Civil #CV-90-0495, FDC #65796.
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