Consumers and health professionals are advised that Pfizer Australia, in consultation with the TGA, is recalling 10 batches of 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.
It has been identified that the affected batches of Gentamicin Injection (listed below) 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.
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.