FDA recall D-0294-2023

Sentara Infusion Services · Class II · drug

Product

GANCICLOVIR ( CYTOVENE) (a)1480MG IN NS 296ML, (b) 740 MG IN NS 336 ML, antiviral, Rx Only, use with a Curlin 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-0294-2023