Medicine recalls
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| Australia: Medicine recall: Typhim Vi Vaccine 25µg/0.5mL |
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The Therapeutic Goods Administration (TGA) advised healthcare professionals and consumers that some batches of Typhim Vi Vaccine (Salmonella typhi Vi polysaccharide typhoid vaccine) have been recalled by the sponsor, Sanofi-Aventis Pty Ltd (trading as Sanofi Pasteur), because they may have lower than expected antigen content, which may result in reduced efficacy. The recalled batches are E1246, G0461, H0078, H0101, H0198 and H0507. This is a precautionary recall and there are no safety concerns for individuals who have received a dose from a recalled batch. While Sanofi Pasteur does not have clinical trial data on the immunogenicity and efficacy of the vaccine with below specification antigen content, Sanofi Pasteur does not recommend revaccination earlier than otherwise indicated.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/safety/alerts-medicine-typhim-121005.htm
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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