FDA recall D-0311-2023

Sentara Infusion Services · Class II · drug

Product

NALBUPHINE (a) 1.5MG IN 1.5ML NS, (b) 2.5MG IN 2.5ML NS, SYRINGE, pain, 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-0311-2023