FDA recall D-0404-2019

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy · Class II · drug

Product

Cyclosporin liquid 0.5%, Rx, plastic dropper bottle

Reason for recall

Lack of sterility assurance.

Distribution

Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.

Key facts

Status: Terminated
Initiation date: 2019-01-02
Report date: 2019-01-09
Termination date: 2023-03-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Roseburg, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0404-2019