Leader brand Eye Irritation Relief 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 Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%), packaged in 0.5 FL…

Recall number

D-0297-2024

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 Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0087-1