US Drug Recall Register
Class I · High risk Ongoing Initiated Feb 24, 2023 (4 years ago)

Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5…

Class I — High risk. Reasonable probability of serious harm or death.

Why it was recalled

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

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.

Recalling firm
Global Pharma Healthcare Private Limited
Origin
N/A, India
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0488-2023

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.