| TGA Action ID |
RC-2023-RN-00452-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Technetium-99m and Technetium-99m Macrosalb
Batch numbers: Tc99m Elution E and Tc99m Macrosalb B
Dose numbers: Rx 680915 and Rx 680916
This product is exempt from the ARTG |
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
One unit dose of Tc99m and one unit dose of Tc99m Macrosalb were recalled on 12 May 2023 due to incorrect packaging and labelling.
Due to a mix-up between the two labels in the packaging process, the units were packaged with the incorrect external labelling. This resulted in the Tc99m Macrosalb dose being transported with the incorrect transportation conditions.
The Tc99m had been consumed in the Technegas machine and could not be returned, however was not administered to the patient. The Tc99m Macrosalb was returned to GMS unused, presenting further no risk to patient.
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 affected doses were recalled on Friday 12th May 2023. A formal written notification will be sent to the customer.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Action Commencement Date |
15/05/2023 |
| Responsible Entity |
|
| Contact Information |
08 9445 9644 - Global Medical Solutions Australia Pty Ltd |