Delsam Pharma's 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 Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15…

Recall number

D-0921-2023

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

Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15.