FDA-Drug2023-03-29Class I
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.
Global Pharma Healthcare Private Limited
Hazard
Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
Sold states
Product was imported by one distributor, Delsam Pharma, LLC, who further distributed the product via internet sales Nationwide in the USA.
Affected count
50,000 tubes
Manufactured in
A - 9 Sidco Pharmaceutical Complex, Thiruporur, Chennai, N/A, India
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0488-2023Don't want to check this manually?
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