| TGA Action ID |
RC-2026-RN-00778-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Gemcitabine 1,425mg in 0.9% Sodium Chloride in Polyolefin Bag (Freeflex) for Intravenous Infusion
Batch Number: BB26096810
Expiry Date: 14/12/2026
ARTG Exempt |
| ARTG Number |
|
| Unique Device Identifier (UDI) |
BB26096810 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
A Gemcitabine infusion bag from BB26096810 was observed to be leaking from the final product container, contained within the clear inner protective packaging. The treating clinician was unable to identify where the leak had occurred.
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 |
Spill was contained within the clear inner protective bag. The product was discarded by the customer. |
| Action Commencement Date |
8/10/2026 |
| Responsible Entity |
|
| Contact Information |
(03) 9565 4300 - Slade Health Head Office |