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Harrow Eye LLC

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0489-2026Class IIFRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.April 17, 2026