FDA recall D-0293-2023

Sentara Infusion Services · Class II · drug

Product

FLUCONAZOLE 200MG NS 100ML, antifungal, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

Reason for recall

Lack of sterility assurance

Distribution

Dispensed to Patients Nationwide.

Key facts

Status
Terminated
Initiation date
2022-12-27
Report date
2023-02-22
Termination date
2026-02-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chesapeake, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0293-2023