FDA recall D-0632-2023

Apollo Care, LLC · Class II · drug

Product

PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe, Solution for IV Use Only. Apollo Care, LLC, 3801 Mojae Ct., Suite 101, Columbia, MO 65202. NDC: 71170-010-10

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-0632-2023