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


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...

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.

Top Stories of 2015

Data integrity was the top story of 2015, followed by quality metrics and sterile injectables contamination.

Related Content


Related Companies




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