FDA recall D-0391-2021

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

Reason for recall

Subpotent and Presence of Particulates .

Distribution

Nationwide in the US

Key facts

Status

Terminated

Initiation date

2021-05-07

Report date

2021-05-26

Termination date

2022-06-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0391-2021