| TGA Action ID |
RC-2026-RN-00806-1 |
| Type of Product |
Medicine |
| Product Name/Description |
PEDMARQSI 8 g / 100 mL solution for injection vial
Product Batch Numbers: 497863, 490176, 490184, 456336 and 467504
Expiry Dates: Mar 2029, Oct 2028, and Dec 2026
Supplied via the Special Access Scheme (SAS) |
| ARTG Number |
476012 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Visible particles were detected during retention sample review of two Pedmarqsi bulk batches. Two additional bulk batches are included in the recall as a precautionary measure.
Pedmarqsi is administered intravenously to paediatric patients receiving cisplatin to reduce the risk of
ototoxicity. Norgine cannot exclude a potential risk if particles are injected, which may include embolic, thrombotic or infusion-site reactions.
To date, no adverse events suggestive of particulate matter-related effects have been identified. |
| Instructions for Customers/Users |
Customers are to:
- Inspect their stock immediately and quarantine any of the affected batches to prevent further use.
- Arrange for destruction of the affected stock according to hospital protocol. |
| Action Commencement Date |
13/10/2026 |
| Responsible Entity |
|
| Contact Information |
cpile@norgine.com - Caroline Pile, Norgine Pty Ltd |