HBW Insight 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


McNeil Recalls Liquid Infants’ Tylenol With Dosing Device Problem

This article was originally published in The Tan Sheet

Executive Summary

McNeil Consumer Healthcare recalls an Infants’ Tylenol product that returned to market in November, after receiving consumer complaints about a problem with the SimpleMeasure dosing device system. The recall marks a misstep in the J&J subsidiary’s comeback from OTC quality control issues.

You may also be interested in...

Acetaminophen Panel To Mull Expanded Dosing, Standard Solid Concentration

FDA is asking a joint advisory panel to consider whether it should restrict firms to one standard acetaminophen concentration for all solid oral dosage single-ingredient pediatric products, among other measures to reduce dosing errors.

FDA Gets Strict On Liquid OTC Dosing Devices In Draft Guidance

Some drug firms may need to alter their product packaging and labeling to comply with FDA's guidance on dosing device labeling for liquid OTCs

Andrx Concerta

Firm has pending ANDAs for generic versions of McNeil's Rx Concerta (methylphenidare hydrochloride) extended-release tablets in 18, 27, 36 and 54 mg formulations. McNeil's exclusivity for the pediatric hyperactivity deficit disorder drug was set to expire March 17, and the firm has filed a citizen petition with FDA "that affects the timing of, and potentially the approval criteria for, ANDA approvals relating to generic Concerta," according to Andrx. McNeil put 300 sales reps behind the drug in 2000 (1"The Tan Sheet," April 24, 2000, In Brief)...


Related Companies

Latest Headlines
See All



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