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.
Recall initiated: 20230224
Status: Ongoing
Classification: Class I
Recall type: Voluntary: Firm initiated