| TGA Action ID |
RC-2024-RN-00106-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Technetium-99m HDP
Batch number: 21595
Dose numbers: 2086136, 2086137, 2086138
ARTG: Exempt |
| ARTG Number |
|
| Action Type |
Product Defect Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Identification of microbial growth in the retrospective sterility test sample.
Compromised sterility may expose patients to infectious agents.
As the affected doses were supplied and administered on 12-Dec-2023, there are no physical units to recall. |
| Instructions for Customers/Users |
Global Medical has written to affected customers to inform them of this issue and monitor any adverse events reported in relation to it.
This action has been closed out on 17/09/2025. |
| Action Commencement Date |
12/02/2024 |
| Responsible Entity |
|
| Contact Information |
02 9503 8100 - Global Medical Solutions |