| TGA Action ID |
RC-2026-RN-00306-1 |
| Type of Product |
Medicine |
| Product Name/Description |
NIVOLUMAB 360MG IN 0.9% SODIUM CHLORIDE IN POLYOLEFIN BAG (FREEFLEX) FOR INTRAVENOUS INFUSION
Batch: BB260411091
Expiry: 31/05/2026
ARTG Exempt |
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Upon receipt of compounded product, Nivolumab, the customer has identified a leaking product within the protective inner clear bag. The spill was contained within the bag and deemed not safe for patient use. The product was discarded and was not administered.
This Recall does not affect any other compounded batches of Nivolumab 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 product was discarded as cytotoxic waste by the customer.
A replacement was required as the customer was able to use other stock to treat the patient. |
| Action Commencement Date |
24/04/2026 |
| Responsible Entity |
|
| Contact Information |
03 9565 4300 - Slade Health Head Office |