FDA recall D-0488-2023

Global Pharma Healthcare Private Limited · Class I · drug

Product

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2023-02-24
Report date
2023-03-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chennai, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0488-2023