| TGA Action ID |
RC-2025-RN-00736-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Paclitaxel compounded infusion
Paclitaxel 66mg in 0.9% Sodium Chloride in Polyolefin bag (Freeflex)
For Intravenous Infusion
Batch: BK250816428
Expiry: 01 Sep 2025 |
| ARTG Number |
|
| Unique Device Identifier (UDI) |
n/a |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
A discrepancy in the leftover volume of the vial used to compound a paclitaxel batch has indicated that there may be the potential for an incorrect dose added to the batch.
This recall does not affect any other compounded batches of paclitaxel or any other Slade Health products.
This batch was distributed to 1 Hospital on 19/08/2025. |
| Instructions for Customers/Users |
- Quarantine affected stock (Slade Health batch BK250816428) on hand to prevent further use.
- Discard the affected batch as cytotoxic waste.
This action has been closed out on 09/12/2025 |
| Action Commencement Date |
22/08/2025 |
| Responsible Entity |
|
| Contact Information |
03 9565 4400 - Slade Health Head Office |