Delsam Pharma's Artificial Eye Ointment recalled over sterility concerns

Recall date

February 24, 2023

Source

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

Official notice title

Global Pharma Healthcare Private Limited recalls Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed…

Recall number

D-0488-2023

FDA classification

Class I

Brand / firm

Global Pharma Healthcare Private Limited

Sold / distributed

Product was imported by one distributor, Delsam Pharma, LLC, who further distributed the product via internet sales Nationwide in the USA.

Why it was recalled

Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.

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 Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed By: Delsam Pharma Lic, Bronx, Newyork 10469, NDC 72570 122 35, UPC 3 72570 12235 3.