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Gentamicin Injection BP 80 mg in 2 mL Steriluer ampoules in packs of 10 or 50
Official notice
8 Oct 2017
Last checked
8 Oct 2017
An official ACCC notice concerns Gentamicin Injection BP 80 mg in 2 mL Steriluer ampoules in packs of 10 or 50. 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. Signs and symptoms of severe allergic reactions can include one or more of the following: • generalised rash • hives or welts (a red, itchy, lumpy rash, like mosquito bites) • a tingling feeling in or around the mouth • stomach pain, vomiting and/or diarrhoea • facial swelling • difficulty with breathing and/or noisy breathing • swelling of the tongue • swelling and/or tightness in throat • difficulty talking and/or hoarse voice • loss of consciousness and/or collapse. Published 2017-10-08.
What to do now
If you or someone you provide care for is using Gentamicin Injection outside of a clinical setting, such as at home, check to see if your medicine is from an affected batch. If it is, return the affected product to your pharmacy for a refund and speak to your health professional as soon as possible to discuss replacement. If you have any questions or concerns about this issue, talk to your health professional.
Recall number
85c9d391-7fd1-488a-9e3c-865dafa3ee0f
Official notice
2017-10-08
The hazard
The hazard
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. Signs and symptoms of severe allergic reactions can include one or more of the following: • generalised rash • hives or welts (a red, itchy, lumpy rash, like mosquito bites) • a tingling feeling in or around the mouth • stomach pain, vomiting and/or diarrhoea • facial swelling • difficulty with breathing and/or noisy breathing • swelling of the tongue • swelling and/or tightness in throat • difficulty talking and/or hoarse voice • loss of consciousness and/or collapse.
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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