| TGA Action ID |
RC-2026-RN-00047-1 |
| Type of Product |
Medicine |
| Product Name/Description |
CISPLATIN 70MG IN 0.9% SODIUM CHLORIDE IN POLYOLEFIN BAG (FREEFLEX) FOR INTRAVENOUS INFUSION
Batch Number: BK251229352
Expiry Date: 28/02/2026
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 product, it was identified that the IV bag had leaked into the sealed, clear inner plastic product bag.
This recall does not affect any other compounded batches of Cisplatin 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 spill was contained within the bag and deemed not safe for patient use and discarded by the treating clinician prior to use. |
| Action Commencement Date |
21/01/2026 |
| Responsible Entity |
|
| Contact Information |
(03) 9565 4400 - Slade Health Head Office |