| TGA Action ID |
RC-2026-RN-00035-1 |
| Type of Product |
Medicine |
| Product Name/Description |
CARBOPLATIN 371MG IN 0.9% SODIUM CHLORIDE IN POLYOLEFIN BAG (FREEFLEX) FOR INTRAVENOUS INFUSION
Batch: BB25112984
Expiry: 12/11/2025
ARTG: Exempt |
| ARTG Number |
|
| Unique Device Identifier (UDI) |
n/a |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
A Carboplatin batch was supplied in an incorrect diluent. The order was for Carboplatin in 5% glucose. A Carboplatin in 0.9% sodium chloride was supplied.
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 |
This product was meant to be administered to the patient on 06/11/2025.
The customer was to complete the Customer Response form confirming the date of administration and whether there were any adverse clinical outcomes as a result of continuing the patient’s treatment with the 0.9% Sodium Chloride diluent. |
| Action Commencement Date |
15/01/2026 |
| Responsible Entity |
|
| Contact Information |
03 9565 4400 - Slade Health Head Office |