| Type of Product |
Medicine |
| TGA Recall Reference |
RC-2017-RN-01281-1 |
| Product Name/Description |
Gentamicin Injection BP 80 mg in 2 mL Steriluer, 10 and 50 packs
Batches/ Expiry:
A115 30.11.2017
A115A 30.11.2017
A115B 30.11.2017
A129 31.12.2017
A297 31.05.2018
A316 31.08.2018
A318 31.05.2018
A342 31.07.2018
A394 31.10.2018
A448 31.12.2018
AUST R: 11376 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
6/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
Pfizer advises that, following an internal investigation, the following batches of Gentamicin Injection BP 80 mg in 2 mL Steriluer are being recalled as they may contain a higher than expected intrinsic constituent (histamine) in the finished product. Histamine administered intravenously or intramuscularly could potentially lead to signs and symptoms of hypersensitivity reactions including anaphylaxis. |
| Recall Action |
Recall |
| Recall Action Instructions |
Pfizer Australia is recalling affected batches to the consumer level.
For further information please see : https://www.tga.gov.au/alert/gentamicin-injection-bp-80-mg-2-ml-steriluer
This action has been closed out on 17/10/2018 |
| Contact Information |
1800 675 229 - Pfizer Medical Information
1800 999 543 - Pfizer Trade Operations |