FDA recall D-1172-2023

Product

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: Out of Specification result observed for low assay

Distribution

Nationwide wide in the USA

Key facts

Status

Terminated

Initiation date

2023-09-07

Report date

2023-09-27

Termination date

2024-02-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1172-2023