US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Sep 23, 2025 (11 months ago)

Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.

What was recalled

Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110, NDC 83863-4272-1.

Recalling firm
Park Avenue Compounding
NDC code
83863-4272-1
Origin
MO, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0178-2026

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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