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EU agency recalls Pacira drug on contamination worries
August 24, 2012 / 10:50 AM / 5 years ago

EU agency recalls Pacira drug on contamination worries

LONDON (Reuters) - The European Medicines Agency said on Friday it had recommended cancer drug DepoCyte be recalled in Europe, where suitable alternative treatments are available, due to sterility concerns at a U.S. plant operated by Pacira Pharmaceuticals.

A recent inspection carried out jointly by France and Britain at Pacira’s manufacturing site in San Diego identified a number of manufacturing deficiencies related to a lack of adequate sterility assurance in the manufacturing process.

The agency said there was no evidence at present of any microbial contamination of products on the market or risk to patients and the recall was a precautionary measure.

Reporting by Ben Hirschler; Editing by Helen Massy-Beresford

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