Rugby brand Polyvinyl Alcohol 1 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 Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby…

Recall number

D-0293-2024

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

Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1325-94