| TGA Action ID |
RC-2026-RN-00878-1 |
| Type of Product |
Medicine |
| Product Name/Description |
[18F]MK-6240 Stabilised Injection
Batch Number: MK6240-261027a
Expiry Date: 27/10/2027
ARTG Exempt |
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Testing showed residual solvent (Acetonitrile) was outside the specification limit for one batch of [18F]MK-6240 .
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 |
All customers were notified of the failed product immediately, requesting acknowledgement of the product's unreleased status and to return affected stock.
No patients were administered the product. |
| Action Commencement Date |
28/10/2026 |
| Responsible Entity |
|
| Contact Information |
02 9515 7908 - SLHD Royal Prince Alfred Hospital Department of Molecular Imaging |