| TGA Action ID |
RC-2026-RN-00395-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Cyclophosphamide 820mg, Doxorubicin 20mg in 0.9% Sodium Chloride in Polyolefin Bag (Freeflex) for Intravenous Infusion
Batch Number: BK260516464
Expiry Date: 21/05/2026
ARTG Exempt |
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Upon receipt of compounded product, Doxorubicin/Cyclophosphamide, the customer has identified a leaking product within the protective inner clear bag. The spill was contained within the bag and deemed not safe for patient use.
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 and discarded by the treating clinician prior to use. |
| Action Commencement Date |
22/05/2026 |
| Responsible Entity |
|
| Contact Information |
03 9565 4300 - Slade Health Head Office |