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TGA Action ID	RC-2023-RN-00334-1
Type of Product	Medicine
Product Name/Description	18F DCFPyL Batch Number: 2670-0628 Date of Manufacture: 11/04/2023 Product is exempt from the ARTG
ARTG Number
Action Type	Recall
Action Level	Hospital
Hazard Classification	Class I
Reason for the Action	Cyclotek Queensland Pty Ltd is a radiopharmaceutical manufacturing facility operating under GMP license number, MI-2015-LI-10055-1. Cyclotek Queensland Pty Ltd is notifying of a reported defective product (cracked vial), supplied to a site on 11th April 2023. Upon notification of the cracked vial, Cyclotek advised the customer to quarantine the product and return to Cyclotek. Given the nature of the product, the recall was initiated prior to TGA notification (as an Immediate Recall Action following the Uniform Recall Procedure for Therapeutic Goods).
Instructions for Customers/Users	The customer was advised to return the vial to the manufacturing site This action has been closed out on 07/03/2024
Action Commencement Date	11/04/2023
Responsible Entity	Cyclotek Queensland Pty Ltd
Contact Information	07 3391 1077 - Cyclotek Queensland