2014 Drug Recalls: Contamination Surge Enters Fifth Year
This article was originally published in The Gold Sheet
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 reported 1,276 drug recalls last year, the third-highest level ever. Inspections of pharmacies that compounded purportedly aseptic injectables drove the numbers, but pharmaceutical manufacturers also contributed as they struggled with particulates, precipitation and other issues.
Injectables eclipsed oral solids as 2012 generated the fourth-most recalls ever. Contamination played a major role, particularly in generating several massive recalls at compounding pharmacies, while there were also contraceptive packaging snafus, problems in confronting tablet mix-ups and other issues that generated drug recalls last year.
There was greenish-black and white filamentous matter in vials that had been recalled. The question confronting FDA investigators at NECC: How could it have gotten there?