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

2014 Drug Recalls: Contamination Surge Enters Fifth Year

This article was originally published in The Gold Sheet

Executive Summary

Microbial and particulate contamination drove drug recalls to historic levels for a fifth year in 2014, FDA recall data shows. But the data still falters in identifying the weakest links in global pharmaceutical supply chain quality.

You may also be interested in...



US FDA Drafts Guidance Advising Holistic Approach To Further Control Particulates

Guidance aligns with USP Chapters <790> and <1790>; encourages risk-based approach to identifying and correcting particulate contamination of sterile injectables to build on recent successes in reducing particulate-driven recalls.

FDA: Despite Improvement, Particulate-Related Injectables Recalls Remain A Concern

The US FDA reports that particulate contamination was the second leading cause of recalls for injectable drugs over a 10-year period. Yet the good news is that the recalls attributed to visible particle contamination has actually gone down. FDA official says it may be premature to celebrate, more work is needed to bring these recalls down and improve the quality of injectable products.

Glass-Related Drug Recalls Decline After Industry Improves Practices

The number of sterile drug recalls from glass delamination, breakage and other sources of contamination has dropped dramatically since 2010, with the exception of several spikes in 2013 and 2014. FDA and other officials attribute the drop to better risk assessments and fuller evaluations of product formulations' interactions with container closure systems. The industry is also exploring the use of a new, reportedly sturdier type of glass vial that eliminates delamination.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS000918

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