Medicine recalls
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| Canada: Voluntary Recall of Sanofi Pasteur Vi polysaccharide typhoid vaccine, Typhim Vi batches with potentially lower than expected antigen content |
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Sanofi Pasteur, in consultation with Health Canada, would like to inform the healthcare professionals and the public of the decision to voluntarily recall several Salmonella typhi Vi Capsular Polysaccharide Vaccine (Typhim Vi) batches with potentially lower than expected antigen content. The results of recent investigations suggest variability in the content of the active component (polysaccharide) in some syringes and 20-dose vials of the following batches that are being recalled: G1122-1, G1557-1, G0182-2, H0176-1. There is no safety concern for individuals who have received a Typhim Vi vaccine dose from a recalled batch. While Sanofi Pasteur does not have clinical trial data on the immunogenicity and efficacy of Typhim Vi with antigen content below specification, Sanofi Pasteur does not recommend revaccination earlier than otherwise indicated.
Please refer to the following website in Health Canada for details:
http://www.hc-sc.gc.ca/dhp-mps/medeff/../typhim_vi_hpc-cps-eng.php
In Hong Kong, Typhim VI (Typhoid Vaccine) (HK-36827) is registered by Sanofi-Aventis Hong Kong Limited and is a prescription-only medicine. Total recall of the product from the market was conducted and relevant news was published on the website of Drug Office on 14 September 2012. And related news has also been released by the FDA and was posted on the website of Drug Office on 29 September 2012.
Ends/ Friday, October 05, 2012
Issued at HKT 14:00 |
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