Delsam Pharma's ARTIFICIAL TEARS Lubricant Eye Drops recalled over manufacturing violations

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-0922-2023

FDA classification

Class II

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

CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

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.