EMA Recommends Precautionary Recall of Ecalta, Luminity Batches
The European Medicines Agency recommended a precautionary recall on batches of the Ecalta anti-fungal medicine and the Luminity diagnostic drug after a review of quality assurance at a U.S. manufacturing site.
Doctors are advised to visually inspect vials of Ceplene and Torisel, treatments considered essential for certain cancer patients, before administering the treatments to patients, the EMA said today in a statement on its website.
The London-based regulator last month said it was reviewing shortcomings identified during an inspection of Ben Venue Laboratories’ manufacturing site in Ohio.
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