2014 Drug Recalls: Contamination Surge Enters Fifth Year
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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Drug Recalls Soared Again in 2013, Driven by Contamination
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.
Contamination, Mix-Ups Drive Up Drug Recall Totals for 2012
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.
What FDA Saw at Compounder Behind Fungal Meningitis Outbreak
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?