Leader brand Lubricant Eye Drops 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 Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single…

Recall number

D-0291-2024

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 Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 70000-0090-1) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 70000-0090-2), Distributed by: Cardinal Health Dublin, Ohio 43017