FDA recall D-0636-2023

Apollo Care, LLC · Class II · drug

Product

VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-185-50

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-0636-2023