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
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-1172-2023More SUN PHARMACEUTICAL INDUSTRIES INC recalls
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