Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Fentanyl citrate Recalled by Park Avenue Compounding Due to CGMP Deviations: Revised interpretation of Acceptable Quality Level...

Date: September 23, 2025
Company: Park Avenue Compounding
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Park Avenue Compounding directly.

Affected Products

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.

Quantity: 189 bags

Why Was This Recalled?

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

Where Was This Sold?

Distributed in Missouri

About Park Avenue Compounding

Park Avenue Compounding has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report