European Medicines Agency recalls DepoCyte

Published: 24-Aug-2012

Inspection finds manufacturing deficiencies at Pacira Pharmaceuticals’ plant in San Diego

The European Medicines Agency has recommended that cancer drug DepoCyte is recalled in Europe, where suitable alternative treatments are available, owing to concerns about sterility at a US manufacturing plant operated by Pacira Pharmaceuticals.

EMA said there is at present no evidence of any microbial contamination of the product on the market or risk to patients. However, the Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the recall as a precautionary measure.

An inspection carried out jointly by France and the UK at Pacira’s manufacturing plant in San Diego in July identified a number of manufacturing deficiencies related to a lack of adequate sterility assurance in the manufacturing process.

The CHMP concluded that these findings pose a theoretical risk of sterility failure, even though currently nothing has indicated that there has been a negative impact on the finished product.

Production and batch release of DepoCyte are currently on hold.

New batches of the lymphomatous meningitis treatment will only be manufactured once all deficiencies have been resolved and a re-inspection has indicated the manufacturing site to be compliant with good manufacturing practice (GMP) requirements.

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