| TGA Action ID |
RC-2020-RN-00534-1 |
| Type of Product |
Medicine |
| Product Name/Description |
TEPADINA 100 mg powder for concentrate for solution for infusion
Batch 1709192/1, 1709192/2 and 1709192/3
Supplied under SAS |
| ARTG Number |
|
| Action Type |
Product Defect Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The manufacturer is warning that the closing of the bottles of one batch of TEPADINA 100 mg powder might not be adequate. If the closing is not adequate the sterility of the product can then no longer be guaranteed.
There have been no reports of injury in relation to this issue to date. |
| Instructions for Customers/Users |
Customers are advised to inspect each vial prior to use to identify any capping issues.
If product is found with a capping issue, customers are advised to immediately quarantine the affected product and inform Medsurge healthcare for return and refund of the product.
This action has been closed out on 23/11/2020 |
| Action Commencement Date |
22/06/2020 |
| Responsible Entity |
|
| Contact Information |
1300 788 261 - Medsurge Customer Service |