PlainRecalls
FDA Drug Critical Class I Ongoing

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.

Reported: March 29, 2023 Initiated: February 24, 2023 #D-0488-2023

Product Description

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.

Reason for Recall

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

Details

Units Affected
50,000 tubes
Distribution
Product was imported by one distributor, Delsam Pharma, LLC, who further distributed the product via internet sales Nationwide in the USA.
Location
Chennai, N/A

Frequently Asked Questions

What product 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.. Recalled by Global Pharma Healthcare Private Limited. Units affected: 50,000 tubes.
Why was this product recalled?
Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 29, 2023. Severity: Critical. Recall number: D-0488-2023.