| TGA Action ID |
RC-2026-RN-00046-1 |
| Type of Product |
Medicine |
| Product Name/Description |
GEMCITABINE 1,160MG IN 0.9% SODIUM CHLORIDE IN POLYOLEFIN BAG (FREEFLEX) FOR INTRAVENOUS INFUSION
Batch Number: BB251219246
Expiry Date: 23/03/2026
ARTG Exempt |
| ARTG Number |
|
| Unique Device Identifier (UDI) |
n/a |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Upon receipt of the batch, it was identified that the line of the closed system attachment was cracked and had leaked into the clear plastic product bag.
This Recall does not affect any other compounded batches of Gemcitabine 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 batch was distributed to the customer on 23/12/2025, and was nominated to be administered to the patient on 29/12/2025.
The IV bag was discarded as cytotoxic waste at the hospital when the leak was identified.
Customers should inspect their stock immediately to determine if they have any remaining stock and if so, quarantine to prevent further use. The affected batch can be discarded as cytotoxic waste.
For further information customers should contact their Key Account Manager.
This action has been closed out on 29/04/2026 |
| Action Commencement Date |
21/01/2026 |
| Responsible Entity |
|
| Contact Information |
03 9565 4400 - Slade Health Head Office |