OFFICIAL-SOURCE RECALL · AUSTRALIA
Eribulin 1 mg/2 mL Solution for Injection Recall: Classification Class II Reason for the Action Dr
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
- Eribulin 1 mg/2 mL Solution for Injection
- Manufacturer
- See official notice
- Lot number
- H250657
- Batch number
- H250657
- Date code
- dates, Date
- Expiration date
- dates, Date
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 Dr. Reddys has identified an out of specification result during stability testing. The assay result reported (93.3 %) is below the registered specification of 95 -100%. Patients receiving this product may be administered a lower-than-intended dose of Eribulin due to assay results below the labelled claim, potentially resulting in reduced efficacy and subtherapeutic exposure with the probability of adverse health consequences being remote. To date, no reports of loss of efficacy or of adverse events associated with this problem have been received. Instructions for Customers/Users Customers are to: - Inspect their stock immediately and quarantine all affected stock (Batch H250657) to prevent further use or supply. - Arrange for collection and credit of affected stock. Action Commencement Date 13/08/2026 Responsible Entity Dr Reddys Laboratories Australia Pty Ltd
Hazard
Classification Class II Reason for the Action Dr. Reddys has identified an out of specification result during stability testing. The assay result reported (93.3 %) is below the registered specification of 95 -100%. Patients receiving this product may be administered a lower-than-intended dose of Eribulin due to assay results below the labelled claim, potentially resulting in reduced efficacy and subtherapeutic exposure with the probability of adverse health consequences being remote. To date, no reports of loss of efficacy or of adverse events associated with this problem have been received. Instructions for Customers/Users Customers are to: - Inspect their stock immediately and quarantine all affected stock (Batch H250657) to prevent further use or supply. - Arrange for collection and credit of affected stock. Action Commencement Date 13/08/2026 Responsible Entity Dr Reddys Laboratories Australia Pty Ltd
Official recall notice
Eribulin 1 mg/2 mL Solution for Injection
Agency: Therapeutic Goods Administration
Official publication date: August 13, 2026
Read the official AU_TGA_DRAC recall notice →SCAN ONCE. KEEP WATCHING.
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