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Novartis recalls meningitis C vaccine in Britain
Feb 27, 09 FDA warningsTwo batches of a Novartis meningitis C vaccine containing a total of 17,000 doses have been recalled in Britain due to contamination fears.
The Swiss drugmaker said on Thursday the decision was a precaution following the failure of a sterility test, adding the move only affected the British market.
The recall followed detection of the bacteria Staphylococcus aureus in some samples from the same batches after they had been transported in tests at varying air pressure.
However, the Medicines and Healthcare products Regulatory Agency (MHRA) said the actual batches sent to Britain were transported by road at constant air pressure and had passed sterility tests before leaving a factory in Italy.
The agency said there was currently no evidence of any risk to children given the vaccine and there had been no reports of any infections following vaccination.
“Novartis are recalling these two batches as a precautionary measure,” MHRA Chief Executive Kent Woods said in a statement.
Novartis’s co-promotion partner in Britain is Sanofi Pasteur MSD, a 50/50 joint venture between Sanofi-Aventis and Merck & Co .
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