Medicine recalls
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| Australia: Medicine recall: Infanrix hexa vaccine |
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The Therapeutic Goods Administration (TGA) advised healthcare professionals and consumers that six batches of Infanrix hexa have been recalled by the sponsor, GlaxoSmithKline Australia (GSK). The recalled batches are A21CB144A, A21CB188D, A21CB188E, A21CB190A, A21CB197A and A21CB221B. Infanrix hexa is a vaccine used to prevent six diseases: diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio) and Haemophilus influenzae type b (Hib). It is given to children as part of the National Immunisation Program (NIP) and may be given to young children under the age of 8 years who have not been previously vaccinated.
This precautionary recall is being taken because a surface in the area where one of the manufacturing steps for the vaccine takes place was found to have a small amount of contamination with the bacterium Bacillus cereus, an organism commonly found in food and soil. No contamination of the ingredients or in the vaccine itself was found.
GSK has confirmed that the efficacy and safety of the vaccine remain unchanged, and it does not believe this issue poses a health risk to the children who have received it. All of the identified batches passed the quality assurance testing, including sterility testing, required for the vaccine to be released for use in Australia.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/safety/alerts-medicine-infanrix-121011.htm
In Hong Kong, Infanrix Hexa Vaccine (HK-48745) is registered by GlaxoSmithKline Limited (GSK) and is a prescription-only medicine. GSK confirmed that the affected batches had never been imported to Hong Kong and hence the recall in Australia does not affect Hong Kong. News regarding the overseas recall of Infanrix Hexa vaccine has been released by the Department of Health and was posted on the website of Drug Office on 8 October 2012.
Ends/ Thursday, October 11, 2012
Issued at HKT 14:00 |
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