FDA recall D-0290-2023

Sentara Infusion Services · Class II · drug

Product

DOBUTAMINE, (a) 1080MG IN D5W 270ML, (b) 760MG IN D5W 190ML, ionotrop, used with a home pump, 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-0290-2023