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TGA Action ID	RC-2023-RN-00524-1
Type of Product	Medicine
Product Name/Description	Technetium-99m & Technetium-99m labelled radiopharmaceuticals: Tc99m DTPA, Tc99m DTPA Pulmonary Ventilation, Tc99m Neurolite and Tc99m Mebrofenin Dose Rx Numbers: 2034039, 2034040, 2034044, 2034088, 2034168, 2034185, 2034203, 2034276, 2034288 and 2034391 Expiry date: 25 May 2023 Product is exempt from the ARTG
ARTG Number
Action Type	Recall
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	A malfunction of the Single Channel Analyser, used for quality control testing during the production run, resulted in the affected products unable to be QC tested. As QC testing was unable to be performed for the affected products, its radiochemical purity was unable to be confirmed. There is a risk that the product does not meet its labelling requirements and may result in a non-diagnostic scan. The impacted doses were not used by the customers. Given the nature of the product, this action was undertaken prior to TGA notification (Immediate Recall Action as defined within the URPTG).
Instructions for Customers/Users	The impacted doses were recalled on 26 May 2023. A formal written notification will be sent to the customers.
Action Commencement Date	7/06/2023
Responsible Entity	Global Medical Solutions Australia Pty Limited
Contact Information	02 9503 8100 - Global Medical Solutions Australia