Genzyme recalling Fludara over CMO Ben Venue sterility fears

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Sterility fears have prompted Genzyme to recall 9,380 vials of Fludara manufactured by Ben Venue Laboratories.

Quality shortcomings at Ohio-based CMO (contract manufacturing organisation) Ben Venue have led to recalls around the world. Sanofi-owned Genzyme is the latest to initiate a recall, pulling 1,876 packs, which totals 9,380 vials, of Fludara (fludarabine phosphate) 50mg off shelves in the US.

Genzyme cited the GMP (good manufacturing practice) deficiencies regulators found at Ben Venue in November in its justification of the recall. These shortcomings meant there is a “lack of assurance of sterility​” for the packs of Fludara, a chemotherapy drug used to treat chronic lymphocytic leukaemia.

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