FDA recall D-0289-2021

SUN PHARMACEUTICAL INDUSTRIES INC · Class III · drug

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

Distribution

Nationwide and Australia

Key facts

Status: Terminated
Initiation date: 2021-02-22
Report date: 2021-03-10
Termination date: 2022-01-21
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0289-2021