| TGA Action ID |
RC-2026-RN-00632-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Fludeoxyglucose (18F) Injection (FDG)
Batch: FDG260724A
Expiry: 24 Jul 2026
ARTG Exempt |
| ARTG Number |
|
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Batch FDG260724A failed sterility result due to the presence of Lederbergia (Bacillus) sp at 14 days of incubation.
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 |
Customers are to:
- Follow the patient management advice described in the customer letter. |
| Action Commencement Date |
24/08/2026 |
| Responsible Entity |
|
| Contact Information |
07 3646 4404 - Royal Brisbane and Women’s Hospital Department of Nuclear Medicine and Queensland PET Service |