| TGA Action ID |
RC-2026-RN-00257-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Mitomycin C 0.5mg (0.5mg/Ml, 0.05%) In Syringe (Terumo) For Ocular Use
Batch: BK260330847
Expiry: 15/04/2026
ARTG Exempt |
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
A batch of five Mitomycin syringes was supplied containing a lower dose than specified on the product label. The concentration of the syringes supplied was 0.4mg/mL rather than 0.5mg/mL as described on the product label.
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 02/04/2026. The product was immediately quarantined and discarded by the customer upon identification of the problem, prior to use on the patient. |
| Action Commencement Date |
9/04/2026 |
| Responsible Entity |
|
| Contact Information |
(03) 9565 4300 - Slade Health Head Office |