FDA recall D-0281-2023

Sentara Infusion Services · Class II · drug

Product

CEFOXITIN (a) 1GM IN NS 50ML,(b) 2GM IN NS 100ML, used with a home pump. 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-0281-2023