PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: March 10, 2021 Initiated: February 22, 2021 #D-0289-2021

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

Reason for Recall

Subpotent

Details

Units Affected
37,400 cartons/60 vials per carton
Distribution
Nationwide and Australia
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: 37,400 cartons/60 vials per carton.
Why was this product recalled?
Subpotent
Which agency issued this recall?
This recall was issued by the FDA Drug on March 10, 2021. Severity: Low. Recall number: D-0289-2021.