DRUG RECALL DATA FOR 2003
This article was originally published in The Gold Sheet
Executive Summary
...show a continuing concern with microbial contamination of injectable products – one in five recalls during the year were conducted for this reason. Problems with pharmacy compounding, metal particulates, bulk drug cross-contamination and levothyroxine potency draw FDA inspection attention. FDA’s new electronic recall system is improving internal efficiency, as the agency moves toward real-time notification and the ability to conduct more in-depth recall analyses. With counterfeiting-related recalls continuing, FDA issues a final report containing anti-counterfeiting recommendations and HHS sets up a new task force to address importation concerns. [A nine-page tabulation of drug recalls listed in FDA "Enforcement Reports" during 2003 is included.]
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