| TGA Action ID |
RC-2025-RN-00752-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Fluorouracil 3,850mg in 0.9% Sodium Chloride in Infusor LV 5mL/hr for Intravenous Infusion
Batch Number: BB250814428
Expiry Date: 26 Oct 2025
ARTG Exempt |
| ARTG Number |
|
| 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 this batch has indicated that there is an incorrect dose added to this batch.
This recall does not affect any other compounded batches of Fluorouracil or any other Slade Health products. |
| Instructions for Customers/Users |
Customers should inspect their stock immediately and quarantine affected stock (Slade Health batch BB250814428) on hand to prevent further use, then discard the affected batch as cytotoxic waste.
A replacement product has been compounded by Slade Health
This action has been closed out on 08/12/2025 |
| Action Commencement Date |
29/08/2025 |
| Responsible Entity |
|
| Contact Information |
03 9565 4400 Slade Health Pty Ltd Head Office |