D-0489-2026 Class II Ongoing

Recalled by Harrow Eye LLC — Nashville, TN

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.