| TGA Action ID |
RC-2026-RN-00086-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Cyclophosphamide 1,590mg in 0.9% Sodium Chloride in Polyolefin Bag (Freeflex) for Intravenous Infusion
Batch Number: BW260119719
Expiry Date: 25/03/2026
ARTG Exempt |
| ARTG Number |
|
| Unique Device Identifier (UDI) |
n/a |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Prior to patient treatment, the treating clinician noticed that product container was leaking within the inner protective bag.
This Recall does not affect any other compounded batches of Cyclophosphamide or any other Slade Health products.
Given the nature of the product, this action was undertaken prior to TGA notification (Immediate Market Action as defined within the PRAC). |
| Instructions for Customers/Users |
The spill was contained within the bag and deemed not safe for patient use. It was discarded by the treating clinician prior to use. |
| Action Commencement Date |
2/02/2026 |
| Responsible Entity |
|
| Contact Information |
03 9565 4400 - Slade Health Head Office |