Class IIOngoing

FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL recall

FDA recall D-0409-2025 · initiated Apr 15, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Lack of Assurance of Sterility

Details

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
Recalling company: Apollo Care, LLC
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: MO
Initiated: Apr 15, 2025
FDA report date: May 14, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0409-2025 ↗

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