PRA number
2017/16365
Published date
Product description
Gentamicin Injection BP 80 mg in 2 mL Steriluer ampoules in packs of 10 and 50.
Gentamicin Injection belongs to a group of medicines known as aminoglycoside antibiotics, which work by preventing bacteria from growing and by killing them. Gentamicin Injection is most commonly used to treat serious and potentially life-threatening infections in many different parts of the body, such as chest infections, urinary tract infections and infected wounds or burns. It can be used in adults and children.
Gentamicin Injection is primarily used in hospitals, but it can be dispensed from community pharmacies for use in settings such as nursing homes or local clinics. It is possible that some affected products could have been dispensed to patients for use outside of a clinical setting, such as at home.
The 10 affected batch numbers and expiry dates are:
• Batch A115 expiry date 30 November 2017
• Batch A115A expiry date 30 November 2017
• Batch A115B expiry date 30 November 2017
• Batch A129 expiry date 31 December 2017
• Batch A297 expiry date 31 May 2018
• Batch A316 expiry date 31 August 2018
• Batch A318 expiry date 31 May 2018
• Batch A342 expiry date 31 July 2018
• Batch A394 expiry date 31 October 2018
• Batch A448 expiry date 31 December 2018
AUST R: 11376
Gentamicin Injection belongs to a group of medicines known as aminoglycoside antibiotics, which work by preventing bacteria from growing and by killing them. Gentamicin Injection is most commonly used to treat serious and potentially life-threatening infections in many different parts of the body, such as chest infections, urinary tract infections and infected wounds or burns. It can be used in adults and children.
Gentamicin Injection is primarily used in hospitals, but it can be dispensed from community pharmacies for use in settings such as nursing homes or local clinics. It is possible that some affected products could have been dispensed to patients for use outside of a clinical setting, such as at home.
The 10 affected batch numbers and expiry dates are:
• Batch A115 expiry date 30 November 2017
• Batch A115A expiry date 30 November 2017
• Batch A115B expiry date 30 November 2017
• Batch A129 expiry date 31 December 2017
• Batch A297 expiry date 31 May 2018
• Batch A316 expiry date 31 August 2018
• Batch A318 expiry date 31 May 2018
• Batch A342 expiry date 31 July 2018
• Batch A394 expiry date 31 October 2018
• Batch A448 expiry date 31 December 2018
AUST R: 11376
Reasons the product is recalled
Potential allergic reaction - affected batches of Gentamicin Injection may contain higher than expected amounts of histamine.
The hazards to consumers
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.
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 consumers should 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.
If you have any questions or concerns about this issue, talk to your health professional.
Supplier
Where the product was sold
Nationally
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.