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 Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-506-96

Reported: May 26, 2021 Initiated: May 7, 2021 #D-0391-2021

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 Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-506-96

Reason for Recall

Subpotent and Presence of Particulates .

Details

Units Affected
N/A
Distribution
Nationwide in the US
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 Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-506-96. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: N/A.
Why was this product recalled?
Subpotent and Presence of Particulates .
Which agency issued this recall?
This recall was issued by the FDA Drug on May 26, 2021. Severity: Low. Recall number: D-0391-2021.