| TGA Action ID |
RC-2026-RN-00244-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Gemcitabine 1,615mg in 0.9% Sodium Chloride in Polyolefin Bag (Freeflex) for Bladder Infusion
Batch Number: BW260317269
Expiry Date: 21/06/2026
ARTG Exempt |
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
A Gemcitabine IV bag was labelled with an incorrect route of administration compared to the customer order. The order was for Intravenous Infusion, the product was labelled with "For Bladder Infusion".
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 batch was distributed to the customer on 23/03/2026. The product was discarded by the customer upon identification of the problem, prior to use on the patient.
For further information the customer should contact their Key Account Manager.
This action has been finalised on 25/5/2026. |
| Action Commencement Date |
7/04/2026 |
| Responsible Entity |
|
| Contact Information |
03 9565 4300 - Slade Health Head Office |