| TGA Action ID |
RC-2026-RN-00760-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Fibrase IM IV 100 mg/mL solution for injection, pack size 10 ampoules x 1 mL
Batch Number: G249608
EXpiry Date: 31/07/2029
Supplied via SAS pathway |
| ARTG Number |
|
| Unique Device Identifier (UDI) |
Not applicable. |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Following investigation, certain batches of Fibrase IM IV 100 mg/1 mL are being recalled due to the potential presence of visible particulate contamination in the product. |
| Instructions for Customers/Users |
Customers are to:
- Discontinue use of Batch G249608
- Arrange for the return of any affected stock in accordance with the customer letter |
| Action Commencement Date |
29/09/2026 |
| Responsible Entity |
|
| Contact Information |
02 4339 4239 - Michelle Pruis, ORSPEC Pharma |