Harrow Eye FRESHKOTE Lubricant Eyedrops Sterile 10mL Recall
Harrow Eye LLC is recalling FRESHKOTE Lubricant Eyedrops because the manufacturer cannot guarantee the product remains sterile. Affected lots are 1X68 and 1X69, with an expiration date of 05/31/2027.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a sterile product (eyedrops) where sterility assurance has failed. Loss of sterility in ophthalmic products poses a risk of serious infection, meeting the Class II threshold for severity.
Plain-English summary
Harrow Eye LLC is recalling FRESHKOTE Lubricant Eyedrops, Sterile, 0.33 FL OZ (10mL), distributed nationwide in the United States. The recall affects approximately 50,900 units with lot numbers 1X68 and 1X69, expiring 05/31/2027.
The reason for the recall is lack of assurance of sterility. The manufacturer cannot confirm that these lots maintain their sterile formulation.
Consumers who have this product should discontinue use and consult their healthcare provider if they have any concerns. The FDA classified this as a Class II recall.
The recalled product
- Product
- FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
- Manufacturer
- Harrow Eye LLC
- Hazard
- sterility-failure
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: 1X68
- 1X69
- Exp. Date 05/31/2027.
Distribution
Distributed nationwide across the United States.