| TGA Action ID |
RC-2026-RN-00246-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Pembrolizumab 200mg in 0.9% Sodium Chloride in Polyolefin Bag (Freeflex) for Intravenous Infusion
Batch Number: BW260310404
Expiry Date: 02/06/2026
ARTG Exempt |
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Prior to patient treatment, the treating clinician noticed that the product container was leaking within the inner protective bag.
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 by the hospital when the leak was identified and was not administered to the patient. |
| Action Commencement Date |
31/03/2026 |
| Responsible Entity |
|
| Contact Information |
Slade Health Head Office 03 9565 4300 |