| TGA Action ID |
RC-2026-RN-00573-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Bendamustine HCL 159mg in 0.9% Sodium Chloride in Polyolefin Bag (Freeflex) for Intravenous Infusion
Batch Number: BK260721436
Expiry Date 26/07/2026
ARTG Exempt |
| ARTG Number |
|
| Unique Device Identifier (UDI) |
BK260721436 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Upon receipt of compounded product, Bendamustine, 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.
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 was discarded by the customer. A replacement bag was provided. |
| Action Commencement Date |
29/07/2026 |
| Responsible Entity |
|
| Contact Information |
03 9565 4300 - Slade Health Head Office |