FDA-Drug2023-09-27Class III
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
SUN PHARMACEUTICAL INDUSTRIES INC
Hazard
Subpotent: Out of Specification result observed for low assay
Sold states
Nationwide wide in the USA
Affected count
69,707 cartons
Manufactured in
2 Independence Way, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1172-2023Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief