| TGA Action ID |
RC-2025-RN-00707-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Isozid 0.5 N (Isoniazid) powder for solution for Infusion (Pack of 10 vials)
Batch: 286480A
Expiry Date: 30/04/2026
UDI: PZN 04250018
Supplied via the Special Access Scheme (SAS) |
| ARTG Number |
|
| Unique Device Identifier (UDI) |
PZN 04250018 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Visible particles were detected in a single vial of Isozid 0.5 N (Isoniazid) after reconstitution during ongoing stability studies.
All other vials tested showed no defects, and no corresponding product complaints have been received to date.
There are no other batches affected at this stage. |
| Instructions for Customers/Users |
Customers are to:
- Inspect stock immediately and quarantine affected batch (286480A) to prevent further use.
- Contact Medsurge Healthcare to discuss destruction or return of the product and subsequent credit or replacement.
This action has been closed out on 02/12/2025. |
| Action Commencement Date |
13/11/2025 |
| Responsible Entity |
|
| Contact Information |
customerservice@medsurgehc.com - Medsurge Healthcare |