Medicine recalls
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| Australia: Recall: Gentamicin Injection BP 80mg in 2ml Steriluer: potential for allergic reactions due to higher than expected amounts of histamine |
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The Therapeutic Goods Administration (TGA) announces that Pfizer Australia, in consultation with the TGA, is recalling 10 batches of Gentamicin Injection BP 80mg in 2ml Steriluer ampoules in packs of 10 and 50. The batch numbers and expiry dates are:
- A115 exp 30 November 2017
- A115A exp 30 November 2017
- A115B exp 30 November 2017
- A129 exp 31 December 2017
- A297 exp 31 May 2018
- A316 exp 31 August 2018
- A318 exp 31 May 2018
- A342 exp 31 July 2018
- A394 exp 31 October 2018
- A448 exp 31 December 2018.
It has been identified that the affected batches of gentamicin injection may contain higher than expected amounts of histamine. Histamine injected intravenously or intramuscularly can potentially lead to signs and symptoms of hypersensitivity reactions, including severe allergic reaction (anaphylaxis). The risk of this occurring is increased for patients who are children and patients with severe kidney impairment.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/alert/gentamicin-injection-bp-80-mg-2-ml-steriluer
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Saturday, Oct 7, 2017
Issued at HKT 12:00
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