FDA recall D-0200-2023

Product

Cyclosporine (A) 0.1%; Cyclosporine (A) 0.2%; Cyclosporine (A) 1%; Cyclosporine (A) 2%; Cyclosporine (A) - Corn oil - 1% Oph solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Reason for recall

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-12-22

Report date

2023-02-01

Termination date

2024-07-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Erie, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0200-2023