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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.
Action Commencement Date	29/07/2026
Responsible Entity	Cyclotek NSW Pty Ltd
Contact Information	02 8223 4803 - Cyclotek