Harrow Eye LLC: FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Harrow Eye LLC
- Product
- FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
- Reason / hazard
- Lack of Assurance of Sterility
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide within the United States
- Recall initiated
- 2026-04-17
- Code info
- Lot #: 1X68, 1X69, Exp. Date 05/31/2027.
- Product quantity
- 50,900 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Nashville
- State
- TN
- Country
- United States
- Event id
- 98766
Free daily digest + "My products" watchlist