| TGA Action ID |
RC-2024-RN-00467-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Technetium-99m and Tc-99m Macrosalb
Batch number: Tc99m Elution D and Tc99m Macrosalb A
Unit dose affected: Rx 703526 and Rx 703527
ARTG: exempt |
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Due to a missed step in the dispensing process a unit dose of Tc99m (Rx 703526) and a unit dose of Tc99m Macrosalb (Rx 703527) were dispensed with environmental controls (continuous non-viable particle counts) reading out of specification. |
| Instructions for Customers/Users |
Given the nature of the product, this action was undertaken prior to TGA notification (Immediate Recall Action as defined within the URPTG).
The affected doses were returned to GMS unused
This action has been closed out on 28/07/2024. |
| Action Commencement Date |
7/06/2024 |
| Responsible Entity |
|
| Contact Information |
(08) 9445 9655 - GMS Australia |