FDAHealthApril 17, 2026
Harrow Eye LLC — FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
⚠️ Lack of Assurance of Sterility
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 17, 2026
Nationwide within the United States
What's affected?
- Product
- FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
- Brand
- Harrow Eye LLC
- Lot code
- 1X68
Additional details
Lot #: 1X68, 1X69, Exp. Date 05/31/2027.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 50,900 units.
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