| TGA Action ID |
RC-2026-RN-00916-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Rituximab (Riximyo) 1,000mg in 0.9% Sodium Chloride in Polyolefin Bag (Freeflex) for Intravenous Infusion
Batch Number: BW261027144
Expiry Date: 30/11/2026
ARTG Exempt |
| ARTG Number |
|
| Unique Device Identifier (UDI) |
BW261027144 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Prior to patient treatment, the treating clinician noticed a product leak had occurred. The leak was contained within the clear inner protective packaging.
This Recall does not affect any other compounded batches of Rituximab 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 problem was identified by the treating clinician prior to administration. The product was discarded by the customer when the leak was identified. |
| Action Commencement Date |
9/11/2026 |
| Responsible Entity |
|
| Contact Information |
03 9565 4400 - Slade Health Head Office |