D-0489-2026 Class II Ongoing
FDA drug recall D-0489-2026 was initiated by Harrow Eye LLC on April 17, 2026 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 50,900 units.
Recall Details
- Product Type
- Drugs
- Report Date
- April 29, 2026
- Initiation Date
- April 17, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50,900 units
Product Description
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 1X68, 1X69, Exp. Date 05/31/2027.