| TGA Action ID |
RC-2026-RN-00068-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Rituximab (Riximyo) 770mg in 0.9% Sodium Chloride in Polyolefin Bag (Freeflex) for Intravenous Infusion
Batch: BB26018448
Expiry: 14/02/2026
ARTG Exempt |
| ARTG Number |
|
| Unique Device Identifier (UDI) |
n/a |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Rituximab was supplied to a customer without ice in the shipper. The product is required to be stored at 2-8C. As the storage of this compounded product at room temperature is not supported, the batch was considered unfit for use.
This recall does not affect any other 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 |
A stability assessment determined that the product was not fit for use and it was discarded by the customer. The product was not administered to a patient.
Customers should inspect their stock immediately to determine if they have any remaining stock and if so, quarantine to prevent further use. Please discard the affected batch. |
| Action Commencement Date |
28/01/2026 |
| Responsible Entity |
|
| Contact Information |
03 9565 4400 - Slade Health Head Office |