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: Aug. 5, 1992

Executive Summary

CLASS II -- CEPHRADINE CAPSULES 250 mg, a semi-synthetic cephalosporin, in 100 capsule bottles, under Barr and Major labels. Recall number: D-438-2. Lot number 01550CZ EXP 9/92 (or 10/92 on some Barr labels). Manufacturer: Barr Laboratories, Inc., Pomona, New York. Recalled by: Manufacturer, by letter July 17, 1992. Firm-initiated recall ongoing. Distribution: Nationwide; 11,457 bottles were distributed. Reason: Subpotency. CLASS II -- VARIOUS Rx INJECTABLE DRUG PRODUCTS (a) Atropine Sulfate Injection, USP, 1 ml, in multiple dose vials, (i) 1 mg/ml, (ii) 0.3 mg/ml; (b) Heparin Sodium Injection, 1,000 USP units/ml, in 1 ml single dose vials; (c) Magnesium Sulfate Injection, USP, 50%, 500 mg/ml; in 2 ml single dose vials. Recall number: D-440/443-2. Lot numbers: (a) 1 mg/ml: lot number 311331 EXP 12/94, 320144 EXP 2/95; 0.3 mg/ml: lot number 320154 EXP 2/94; (b) 320282 EXP 3/94; (c) 320141 EXP 7/93, 320219 EXP 8/93, 320086 EXP 7/93. Manufacturer: Lyphomed, Division of Fujisawa USA, Inc., Grand Island, New York. Recalled by: Lyphomed, Division of Fujisawa USA, Inc., Melrose Park, Illinois, by letter July 16, 1992. Firm- initiated recall ongoing. Distribution: (a & b) Nationwide; (c) Nationwide and Hong Kong; (a) 309,375 vials (1 mg/ml) and 2,925 vials (0.3 mg/ml) of Atropine Sulfate were distributed, with the firm estimating that 87,000 vials of 1 mg and 1,000 vials of 0.3 mg product remain on the market; (b) 123,975 vials were distributed, with the firm estimating that 31,000 vials remain on the market; (c) 492,600 vials were distributed, with the firm estimating that 96,000 vials remain on the market. Reason: The vials have a low fill volume. CLASS II UPDATE -- DISOPYRAMIDE PHOSPHATE CAPSULES Recall number: D-435-2, Disopyramide Phosphate Capsules, 100 mg, which appeared in the July 29, 1992 Enforcement Report ("The Pink Sheet" Aug. 3, T&G17) should read: Recalled by: Barr Pharmaceuticals, Inc., Pomona, New York by letter July 9, 1992. CLASS III -- MMI OPTI-UP BRAND BARIUM SULFATE For suspension for use in air contrast examination of the upper gastrointestinal tract, in 312 gram cups. Recall number: D-444-2. Lot number 904920. Manufacturer: Century Pharmaceutical, Inc., Indianapolis, Indiana. Recalled by: MMI, Inc., Southfield, Michigan, by letter April 7, 1992. Firm-initiated recall complete. Distribution: New Jersey, Michigan, Missouri, Texas, South Carolina, Abu Dhabi UAE, Switzerland; 1,536 cups were distributed; firm estimates none remains on the market. Reason: Incorrect expiration date on product. CLASS III -- NATURLAX Sugar free orange flavored psyllium hydrophilic mucelloid, a natural fiber laxative. Recall number: D-439-2. Lot number 910936. Manufacturer: Cenci Powder Products, Inc., Fresno, California. Recalled by: Manufacturer, by telephone and by letters of Jan. 8 and 27, 1992. Firm-initiated recall ongoing. Distribution: California, Florida, Minnesota, New Jersey, Tennessee; 1,224 bottles distributed. Reason: Sugar free product packed in bottles labeled as containing sugar. CLASS III -- TECHNETIUM Tc 99m GENERATOR Sterile, non-pyrogenic, a diagnostic agent for intravenous injection. Recall number: D-436-2. Lot number 9221-4F-071. Manufacturer: The DuPont Merck Pharmaceutical Company, No. Billerica, Massachusetts. Recalled by: Firm notified of the problem by the consignee on June 1, 1992. Unit was returned to the firm on the same date. Firm-initiated recall complete. Distribution: California; 1 unit was distributed and was destroyed 7/15/92. Reason: Unit received less than intended fill. CLASS III -- VALPIN 50, ANISOTROPINE METHYLBROMIDE 50 mg oral tablets, in 100 tablet bottles, a Rx anticholinergic. Recall number: D-437-2. Lot number DN236A 12/94. Manufacturer: DuPont Pharmaceuticals, Garden City, New York. Recalled by: Manufacturer, by letter June 9, 1992. Firm-initiated recall ongoing. Distribution: Nationwide, Puerto Rico; 6,003 bottles were distributed; firm estimates 2,500 bottles remain on the market. Reason: Product does not meet content uniformity specifications.

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

PS021303

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