| TGA Action ID |
RC-2026-RN-00608-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Irinotecan HCL 206mg In 0.9% Sodium Chloride in Polyolefin Bag (Freeflex) for Intravenous Infusion
Batch Number: BK260726123
Expiry Date: 27/09/2026
ARTG Exempt |
| ARTG Number |
|
| Unique Device Identifier (UDI) |
BK260726123 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Upon receipt of compounding product, Irinotecan HCL, the customer has identified a leaking product within the protective inner clear bag. The spill was contained within the bag and deemed not safe for patient use. The product was discarded and not administered.
This market action does not affect any other compounded batches of Irinotecan HCL or any other Slade Health products.
Given the nature of the product, this action was undertaken prior to TGA notification (Immediate Market Action as defined within the PRAC). |
| Instructions for Customers/Users |
The product has been discarded by the customer.
A replacement product was not provided as alternate stock was already available at the hospital. |
| Action Commencement Date |
10/08/2026 |
| Responsible Entity |
|
| Contact Information |
03 9565 4300 - Slade Health Head Office |