FDA recall D-0635-2023

Product

Ketamine Injection, 50 mg per 5 mL (10 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-050-05

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-0635-2023