...include a surge in Class I-rated actions. Altogether, 27 drug products were recalled that were judged to pose a serious health threat, about two-thirds of which were contaminated. Several contamination-related recalls listed by FDA during the year were associated with FDA inspection findings of significant GMP deviations, including a Class I action involving nine injectable products by a pharmacy compounder. Agency concern about inadequate controls to prevent labeling and packaging mixups prompted a national repacker to recall 174 drug products, swelling the total for the year. FDA is stressing the contamination risks of non-sterile products and is working with industry to upgrade microbial testing practices. [A 12-page tabulation of drug recalls listed in FDA "Enforcement Reports" during 2006 is included.]
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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