| TGA Action ID |
RC-2026-RN-00724-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Cisplatin 57.6mg in 0.9% Sodium Chloride in Polyolefin Bag (Freeflex) for Intravenous Infusion & Cisplatin 75mg in 0.9% Sodium Chloride in Polyolefin Bag (Freeflex) for Intravenous Infusion
Cisplatin 57.6mg in 0.9% Sodium Chloride in Polyolefin Bag (Freeflex) for Intravenous Infusion
Batch number: BK26093431
Expiry: 03/11/2026
Cisplatin 75mg in 0.9% Sodium Chloride in Polyolefin Bag (Freeflex) for Intravenous Infusion
Batch number: BK26093468
Expiry: 02/11/2026
ARTG Exempt |
| ARTG Number |
|
| Unique Device Identifier (UDI) |
BK26093431, BK26093468 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Upon receipt of the product two Cisplatin infusion bags were found to be leaking within the protective clear inner 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 protective clear inner bag and deemed not safe for patient use. The 2 single dose units were discarded and not administered. Replacement stock was supplied to the customer. |
| Action Commencement Date |
21/09/2026 |
| Responsible Entity |
|
| Contact Information |
03 9565 4300 - Slade Health Head Office |