Pink Sheet is part 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

MCNEIL TYLENOL CHILDREN'S ELIXIR RECALL IS A CLASS II

Executive Summary

MCNEIL TYLENOL CHILDREN'S ELIXIR RECALL IS A CLASS II action under FDA's system of classifying potential hazard indicating that the "possibility of serious consequence is remote." In a July 10 "Weekly Enforcement Report," FDA announced that the firm recalled 7 batches of the liquid Tylenol product in 4 and 16 ounce bottles. Earlier, McNeil had discovered traces of mold and yeast growing in samples examined during routine quality control testing procedures. According to the Johnson & Johnson subsidiary, the problem began when the product was reformulated to go alcohol-free. All contaminated batches were manufactured before March 1985, and the product has been reformulated since then, a McNeil spokesman indicated. In a July 18 press release, the company said that it had told whslrs. nationwide to return batches of the product. McNeil maintained that none of the contaminated batches had reached retailers' shelves. According to the FDA, the order requires distributors to return the recalled lots of the product, wherever it is. FDA indicated the 370,386 of the 4 ounce bottles were distributed in batch numbers SSF 228, SSF 229, SSF 233, SL4321, SP4462 and SL4309, and 6,701 bottles were distributed in lot number SH3865. The Tylenol Children's Elixir recall generated considerable lay media attention during the week of July 18-19. Stories of the recall appeared in major national media on July 18-19.

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

UsernamePublicRestriction

Register

LL1135415

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