FDA-Drug2023-04-05Class II

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

Apollo Care
Hazard

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

Sold states
MO
Affected count
215 bags
Manufactured in
3801 Mojave Ct Ste 101, N/A, Columbia, MO, United States
Products
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

Official notice

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

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