Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

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.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

Latest Headlines
See All
UsernamePublicRestriction

Register

PS022291

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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