Product: Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.
Reason for recall: Lack of Assurance of Sterility: Complaints received of defective container closure.
Recall initiated: 20220802
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated