Artificial Tears Lubricant Eye Drops recalled over sterility concerns

Recall date

January 30, 2023

Source

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

Official notice title

Global Pharma Healthcare Private Limited recalls Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distribu…

Recall number

D-0919-2023

FDA classification

Class I

Brand / firm

Global Pharma Healthcare Private Limited

Sold / distributed

Product was distributed to two distributors who further distributed Nationwide in the USA.

Why it was recalled

Non-Sterility: FDA analysis found unopened products to have bacterial contamination.

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

Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.