Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France NDC 47335-506-96

Recall Number: D-1172-2023

Firm: SUN PHARMACEUTICAL INDUSTRIES INC

Classification: Class III

Status: Terminated

Report Date: 20230927

Initiation Date: 20230907

Termination Date: 20240213

Reason for Recall

Subpotent: Out of Specification result observed for low assay

Product Description

Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France NDC 47335-506-96