| TGA Action ID |
RC-2026-RN-00845-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Fludeoxyglucose (18F) Injection (FDG)
Batch Number: 4210-4146
Expiry Date: 13-Oct-2026
ARTG Exempt |
| ARTG Number |
|
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
There has been a discrepancy with the amount of activity and volume of product FDG 4210-4146, where more activity and volume had been supplied than stated on the label and release form.
Whilst the activity and volume had exceeded the amount ordered, there are no product quality problems with the batch FDG 4210-4146. There may have been excess activity to what was required in the vial supplied for all patient dosing.
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 |
Notification of the problem was made to all affected customers at the time of awareness. A detailed investigation will occur to determine the root cause of this product alert. |
| Action Commencement Date |
21/10/2026 |
| Responsible Entity |
|
| Contact Information |
03 9467 4966 - Roopa Kothapalli, Cyclotek Melbourne |