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.

Recall Number: D-1328-2022

Firm: CIPLA

Classification: Class II

Status: Terminated

Report Date: 20220817

Initiation Date: 20220802

Termination Date: 20231127

Lack of Assurance of Sterility: Complaints received of defective container closure.

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.