| TGA Action ID |
RC-2025-RN-00974-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Belimumab 800mg in 0.9% Sodium Chloride in Polyolefin Bag (Freeflex) for Intravenous Infusion
Batch: BB25112822
Expiry Date: 06/11/2025
ARTG: Exempt |
| ARTG Number |
|
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
A temperature excursion occurred with the vials that were used to compound this batch which may have resulted in a product with a reduced potency of drug. A lack of therapeutic effect may result from this event. |
| Instructions for Customers/Users |
Due to the impact of the incorrect storage of the starting materials there is an unknown therapeutic impact of this batch. The treating physician should assess the impact of the underdosage for this patient treatment
This action has been finalised on 27/2/2026. |
| Action Commencement Date |
17/11/2025 |
| Responsible Entity |
|
| Contact Information |
03 9565 4400 - Slade Health Head Office |