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

Leaking Heat Cells In Pfizer's ThermaCare HeatWraps Prompt Recall

Executive Summary

Firm's consumer health division extends to consumer level a recall it advised retailers and distributors about on Oct. 2 because products from the six lots have a potential to leak ingredients contained in heat cell wraps. A leaking heat cell in a HeatWrap could cause skin injuries such as burns, blisters or skin irritation on the applied areas.

You may also be interested in...



FDA GMP Warning Letters Review: Foreign Drug Product Firms Hit Hard On GMP Basics

Many of the 30 drug product firms that received FDA warning letters in 2016 were foreign cosmetics and hygiene manufacturers that appeared to need education on US GMP requirements. Another major focus in letters to drug product firms last year was sterility assurance in the US and abroad.

Zecuity Redesign Got Migraine Patch Through FDA, But Burning Continued

FDA worries about burning and scarring with the battery-powered Zecuity patch prompted NuPathe to reconfigure the drug-device combo; our Drug Review Profile shows how FDA thought the problem was solved, but adverse reaction reports soon after launch led to marketing suspension.

Teva Zecuity's Safety: Burns Go From Non-Issue In Label To Product Puller

Fate of migraine patch remains uncertian after 'large number' of patients suffer burns and scars; adverse event was issue during review of transdermal sumatriptan product, but didn't even make it into labeling; nine months later the problems have forced Teva to suspend marketing.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS124319

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