Pfizer Australia Pty Ltd — Gentamicin Injection BP 80 mg in 2 mL Steriluer ampoules in packs of 10 or 50
What are the defects?
Potential allergic reaction - affected batches of Gentamicin Injection may contain higher than expected amounts of histamine.
What are the hazards?
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.
What should consumers do?
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.
Therapeutic Goods Administration is the responsible regulator for this recall.