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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.

CountryAustraliaPublishedJuly 26, 2026Last updatedJuly 26, 2026Official source last checkedAugust 14, 2026 at 7:44 PM UTC

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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

Read the official AU_TGA_DRAC recall notice →

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