| TGA Action ID |
RC-2026-RN-00887-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Cyclophosphamide 110mg in 0.9% Sodium Chloride in Polyolefin Bag (Freeflex) for Intravenous Infusion
Batch Number: BK261019456
Expiry Date: 21/12/2026
ARTG Exempt |
| ARTG Number |
|
| Unique Device Identifier (UDI) |
BK261019456 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Prior to patient treatment, a labelling discrepancy was identified on the product labels. The labelling discrepancy involved an incorrect drug name and dosage.
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 affected stock was quarantined and discarded by the customer as per site policy.
Replacement product was supplied to the customer. |
| Action Commencement Date |
30/10/2026 |
| Responsible Entity |
|
| Contact Information |
03 9565 4300 - Slade Health Head Office |