Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA Recalls & Court Actions: March 14 & 21, 1990

Executive Summary

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.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS017154

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel