| TGA Action ID |
RC-2026-RN-00706-1 |
| Type of Product |
Medicine |
| Product Name/Description |
FLEBOGAMMA 10%DIF normal immunoglobulin (Human) 20g/200ml intravenous use injection vial
Batch: G04K192351
Expiry: 18 December 2027 |
| ARTG Number |
182359 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Increased allergic, hypersensitivity reactions have been reported for one batch, G04K192351, of FLEBOGAMMA DIF 10% 200ml. |
| Instructions for Customers/Users |
Customers are to:
- Identify and quarantine any units from batch G04K192351.
- Contact Grifols Australia to arrange for return of the affected units and discuss replacement or credit options. |
| Action Commencement Date |
18/09/2026 |
| Responsible Entity |
|
| Contact Information |
03 9535 9333 - Grifols Australia |