Product: Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35
Reason for recall: cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Recall initiated: 20220831
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated