FDA recall D-0634-2023

Product

FentaNYL 50 mcg/mL (2,500mcg Total Dose), 50 mL Syringe, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-910-25

Reason for recall

Lack of Assurance of Sterility

Distribution

Missouri only

Key facts

Status

Ongoing

Initiation date

2023-05-02

Report date

2023-05-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbia, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0634-2023