Pink Sheet is part of the Business Intelligence Division 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

DRUG RECALL DATA FOR 2000

This article was originally published in The Gold Sheet

Executive Summary

...show the influence of adverse FDA inspection and sample findings. A majority of recalls conducted recently have been prompted by FDA rather than manufacturer quality systems – a disturbing trend from the agency’s point of view. FDA compliance concerns are reflected, in particular, in a significant number of recalls during 2000 involving the potential for product contamination from faulty aseptic processing and the mishandling of beta-lactam products. Six contamination-related recalls drew a Class I rating as did nine involving products with unapproved claims or ingredients. Error and accident reports shed light on manufacturing problems biologic producers are having, but only a limited percentage result in recalls. [An eight-page tabulation of drug recalls listed in FDA "Enforcement Reports" during 2000 begins on p. 12.]
Advertisement

Related Content

Advantage Dose's GMP Issues Mirrored Earlier Problems Affecting Repackers
Advantage Dose's GMP Issues Mirrored Earlier Problems Affecting Repackers
Care-Tech agrees to stop distributing OTC antimicrobial drugs
Care-Tech agrees to stop distributing OTC antimicrobial drugs
Light Pharma to help FDA coordinate review, compliance and inspection programs
Advertisement
UsernamePublicRestriction

Register

PS000028

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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