Contamination Concerns Prompt EMA to Recommend Vistide Recall

The European Medicines Agency (EMU) last month asked for the recall of several products manufactured by Ben Venue Laboratories over particle contamination concerns. At the time, Gilead’s antiviral medication Vistide (cidofovir) was not included on the list of products recommended for recall, as the drug was undergoing sterilization in an effort to lower the risk of harm to patients.

However, according to the EMA, “a good manufacturing practice inspection has now revealed a possible contamination with particles, and the CHMP concluded that the sterilization at the end of the manufacturing process could not guarantee the absence of particles in the vial.”

Based on the new inspection information, the EMA has now recommended recalling the batch of Gilead’s Vistide that was manufactured in Ben Venue Labs. In order to ensure its availability in the European Union, Gilead has secured an alternate supplier for Vistide while dealing with the precautionary recall.

The EMA is currently reviewing all drugs produced by the CMO (contract manufacturing organization) Ben Venue Laboratories at its Ohio plant in the United States. In addition to Gilead, Ben Venue also manufactures drugs for Takeda, Alexion Pharmaceuticals, Astellas Pharma and The Medicines Company.

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