Leader brand Dry Eye Relief packaged in bottles recalled over sterility concerns

Recall date

November 13, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Kilitch Healthcare India Limited recalls Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.33 FL OZ (10 mL) bot…

Recall number

D-0295-2024

FDA classification

Class I

Brand / firm

Kilitch Healthcare India Limited

Sold / distributed

Nationwide within the United States

Why it was recalled

Non-Sterility

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.33 FL OZ (10 mL) bottles, Distributed by Cardinal Health Dublin, Ohio 43017, NDC 70000-0088-1