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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.

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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.

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