| TGA Action ID |
RC-2026-RN-00030-1 |
| Type of Product |
Medicine |
| Product Name/Description |
MITOMYCIN C 2MG (0.4mg/mL, 0.04%) IN 0.9% SODIUM CHLORIDE IN SYRINGE (TERUMO) FOR OCULAR USE
Batch: BB251120430
Expiry: 14/12/2025
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 product was supplied with the wrong diluent. The syringe contained 0.9% sodium chloride, instead of the correct diluent Water for Injection as ordered. |
| Instructions for Customers/Users |
The batch was distributed to the customer on 1/12/2025, and was nominated to be administered to the patient on 1/12/2025.
Customers should inspect their stock immediately to determine if they have any remaining stock and if so, quarantine to prevent further use. The affected batch can be discarded as cytotoxic waste.
For further information customers should contact their Key Account Manager. |
| Action Commencement Date |
16/01/2026 |
| Responsible Entity |
|
| Contact Information |
03 9565 4400 - Slade Health Head Office |