| TGA Action ID |
RC-2026-RN-00593-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Fludeoxyglucose (18F) Injection (FDG)
Batch Number 2210-5958
Expiry Date: 04/08/2026
ARTG Exempt |
| ARTG Number |
|
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
It was identified there was a discrepancy of the recorded activity and volume supplied on the QC Release Forms than the actual activity and volume supplied in the customer vials. As such, the vials may not have met the activity and dose requirements for each customer site.
Inadequate activity / volume does not have a direct risk to patient safety, as each dose is measured for activity prior to patient use. However, it could have an impact on patient treatment if a procedure is delayed or cancelled.
Given the nature of the product, this action was undertaken prior to TGA notification (Immediate Action as defined within the PRAC). |
| Instructions for Customers/Users |
Customers were contacted immediately upon awareness of the problem, and informed of the discrepancy of the recorded activity / volume on the QC Release forms compared to the actual activity / volume received in the vials.
Most patients were able to receive their intended dose, however two customers missed one patient dose each due to the discrepancy. |
| Action Commencement Date |
10/08/2026 |
| Responsible Entity |
|
| Contact Information |
Lisa.Tai@cyclotek.com - Lisa Tai, Cyclotek Queensland |