FDA DrugsClass II
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashvi...
Published: April 29, 2026Recall ID: D-0489-2026Category: drugsCountry: US
Reason for Recall / Hazard
Lack of Assurance of Sterility
Product Description & Identification
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Additional Source Details
| Field | Value |
|---|---|
| City | Nashville |
| State | TN |
| Event id | 98766 |
| Address 1 | 1a Burton Hills Blvd Ste 200 |
| Address 2 | N/A |
| Code info | Lot #: 1X68, 1X69, Exp. Date 05/31/2027. |
| Postal code | 37215-6187 |
| Report date | 20260429 |
| Product type | Drugs |
| Product quantity | 50,900 units |
| Reason for recall | Lack of Assurance of Sterility |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260417 |
| Initial firm notification | Letter |
| Center classification date | 20260423 |
Overview
- Recalling FirmHarrow Eye LLC
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the United States