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Pfizer recalls contaminated IV drugs

Company recalls antibiotics and anti-emetics manufactured by Claris Laboratories due to floating matter and concerns over sterility

Pfizer has recalled batches of the antibiotics metronidazole and ciprofloxacin and the anti-emetic ondansetron after the manufacturer, India-based Claris Laboratories, discovered contamination in the plastic intravenous (IV) bags containing the drugs. All contaminated products are believed to have been made on the same production line.

The FDA website has reported that the white substance floating in a bag of metronidazole was identified by microbiological analysis as Cladosporium mould. Another bag, containing ondansetron, is currently under analysis.

Administering non-sterile products intravenously could result in potentially life-threatening infections, particularly in immunocompromised patients.

The products have only been distributed in the US. Under FDA guidance, Pfizer has recalled all products already distributed and has halted distribution of the remaining products affected by the recall: of the approximately 1.7m bags received from Claris, approximately 80 per cent, or 1.3m, remain in Pfizer's control.

7th June 2010

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