| TGA Action ID |
RC-2026-RN-00920-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Fludeoxyglucose (18F) Injection (FDG)
Batch Number: 2210-6155
Expiry Date: 09/11/2026
ARTG Exempt |
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Cyclotek Queensland has reported that the incorrect product box (FDG 2210-615) was delivered by the courier.
The product did not meet the activity and dose requirements of the customer.
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 |
Clinical sites were notified through an Immediate Recall notification.
Affected stock was returned to Cyclotek and customers were provided with the correct stock. |
| Action Commencement Date |
10/11/2026 |
| Responsible Entity |
|
| Contact Information |
07 3391 1077 - Cyclotek Queensland |