FDA recall D-0409-2025

Apollo Care, LLC · Class II · drug

Product

FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use Only), Sterile, Single-Use Container, Rx Only, Apollocare, 3801 Mojave Ct, Ste 101, Columbia, MO 65202, NDC 71170-950-25

Reason for recall

Lack of Assurance of Sterility

Distribution

Key facts

Status: Ongoing
Initiation date: 2025-04-15
Report date: 2025-05-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Columbia, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0409-2025