OFFICIAL-SOURCE RECALL · AUSTRALIA
Bendamustine HCL 159mg in 0.9% Sodium Chloride in Polyolefin Bag Recall: Classification Class II Reason for
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
CHECK THE ITEM YOU OWN
Is your product affected?
- Brand
- See official notice
- Product
- Bendamustine HCL 159mg in 0.9% Sodium Chloride in Polyolefin Bag (Freeflex) for Intravenous Infusion
- Manufacturer
- See official notice
- Lot number
- numbers, BK260721436
- Batch number
- numbers, BK260721436
- Date code
- dates, Date 26/07/2026
- Expiration date
- dates, Date 26/07/2026
The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
Why this product was recalled
Classification Class II Reason for the Action Upon receipt of compounded product, Bendamustine, 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. The product was discarded and not administered. 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 product was discarded by the customer. A replacement bag was provided. Action Commencement Date 29/07/2026 Responsible Entity Slade Health Pty Ltd
Hazard
Classification Class II Reason for the Action Upon receipt of compounded product, Bendamustine, 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. The product was discarded and not administered. 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 product was discarded by the customer. A replacement bag was provided. Action Commencement Date 29/07/2026 Responsible Entity Slade Health Pty Ltd
Official recall notice
Bendamustine HCL 159mg in 0.9% Sodium Chloride in Polyolefin Bag (Freeflex) for Intravenous Infusion
Agency: Therapeutic Goods Administration
Official publication date: July 26, 2026
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