FDA recall D-0487-2023

Apollo Care · Class II · drug

Product

Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25

Reason for recall

Lack of assurance of sterility: Suspected microbial growth present on external label packaging.

Distribution

Key facts

Status: Ongoing
Initiation date: 2023-02-08
Report date: 2023-04-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Columbia, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0487-2023