FDA Contaminant Warning for Genzyme Drug Products
Five months after discovery of a virus in one of its medical manufacturing plants, the Maine pharmaceutical company Genzyme faces another set of contamination problems and further potential injury for unsafe drug products on market.
Foreign particles including bits of steel, non-latex rubber, and fiber have been identified in five Genzyme drug products used to treat rare genetic disorders. Two affected drugs - Cerezyme and Fabrazyme - have had their production reduced after the viral contamination was detected in its Allston Landing plant this June.
FDA officials suggest potential serious drug contaminant injury could include blood vessel blockages and life-threatening allergic reactions, though no such adverse events have been reported.
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