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.

D-0488-2023

February 24, 2023

Class I

Product summary

Firm: Global Pharma Healthcare Private Limited
Event: Event 91768
Status: Ongoing
Classification: Class I
Quantity: 50,000 tubes
Official record key: drug-enforcement:D-0488-2023

Official wording

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

Code information: Batch # H29, Exp. Date 11/30/2023

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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