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TGA Action ID	RC-2026-RN-00565-1
Type of Product	Medicine
Product Name/Description	Fludeoxyglucose (18F) Injection (FDG) Batch Number: 6210-067 Expiry: 27/07/2026 ARTG Exempt
ARTG Number
Action Type	Recall
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	Cyclotek was notified of a defective product (cracked vial), that was supplied to a customer site on 27 July 2026. The defect was identified upon receipt and was returned to the manufacturing facility. A new vial was supplied. 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	Product was not used and was returned to Cyclotek as soon as possible. New vial dispensed and sent to customer to cover patient doses. This action has been closed out on 08/09/2026
Action Commencement Date	29/07/2026
Responsible Entity	Cyclotek NSW Pty Ltd
Contact Information	02 8223 4803 - Cyclotek