FDA recall D-0646-2023

Product

FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-950-25

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-0646-2023