| TGA Action ID |
RC-2026-RN-00615-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Eribulin 1 mg/2 mL Solution for Injection
Batch number: H250657
Manufacture Date: June 2025
Expiry Date: May 2027 |
| ARTG Number |
390346 |
| Action Type |
Recall |
| Action Level |
Hospital |
| 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 |
|
| Contact Information |
1800 733 397 - Dr. Reddy's Laboratories |