Please login to the form below

Not currently logged in
Email:
Password:

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

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Cuttsy + Cuttsy

How do you understand what patients really need, without actually living their lives? How do you walk in someone else’s...

Latest intelligence

Products come and go, but a pharma company’s most valuable, durable asset is its reputation, writes Duncan Mackenzie-Reid and Simon Grist
...
Erik
A quest for innovative solutions
UCB looks to the future through a PRISM...
Big data, privacy and the rise of genomic testing
Blue Latitude Health speaks to Johan Christiaanse, Marketing Director at BGI, to find out how the medical profession can overcome one of the major barriers to precision medicine – big...

Infographics