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DRUG RECALL DATA FOR 2002

This article was originally published in The Gold Sheet

Executive Summary

...show a significant increase in potency-related product failures, including several attributed to defects in delivery systems. Other types of container defects contributed to an upsurge in contamination-related recalls during the year. Recalls prompted by FDA inspection findings, including those attributed to "lack of sterility assurance," continued to comprise a majority of the total, extending a recent trend. Labeling mix-ups were also more numerous last year compared with 2001. Dissolution failures, on the other hand, dropped to a three-year low. Counterfeiting continued to plague both the chemical and biotech industries. FDA is developing a new web-based recall reporting system to provide consumers "real-time" access to information on product quality problems.
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