Fentanyl 500mcg and Ropivacaine HCl 250mg added to 0 recalled over sterility concerns

Recall date

February 8, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Apollo Care recalls Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only…

Recall number

D-0487-2023

FDA classification

Class II

Brand / firm

Apollo Care

Sold / distributed

MO

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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