| TGA Action ID |
RC-2026-RN-00037-1 |
| Type of Product |
Medicine |
| Product Name/Description |
BORTEZOMIB 2.9MG IN SYRINGE (TERUMO) FOR INTRAVENOUS USE
Batch Number: BB25125302
Expiry Date: 05/02/2026
ARTG: Exempt |
| ARTG Number |
|
| Unique Device Identifier (UDI) |
n/a |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The syringe was provided with an incorrect route of administration printed on the label. The product was labelled for “Intravenous Use” rather than “Subcutaneous Use” as ordered.
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 batch was distributed to the customer on 06/12/2025, and was nominated to be administered to the patient on 10/12/2025.
Customers should inspect their stock immediately to determine if they have any remaining stock and if so, quarantine to prevent further use.
For further information customers should contact their Key Account Manager.
This action has been closed out on 24/04/2026 |
| Action Commencement Date |
16/01/2026 |
| Responsible Entity |
|
| Contact Information |
03 9565 4400 - Slade Health Head Office |