United StatesFentanyl citrate 2 mcg/mL with ropivacaine 0.2% in normal saline, 150 mL bag (NDC 83863-4272-1), Lot #20250507-01D93C, exp. 11-04-2025, distributed by Park Avenue Compounding, Saint Louis, MO, and sold in Missouri, is being recalled. The recall was initiated because of CGMP deviations involving a revised interpretation of Acceptable Quality Level (AQL) results; 189 bags are affected.
What's being 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, Saint Louis, MO, United States.
How to identify it
Lot # 20250507-01D93C, Exp Date: 11-04-2025
The hazard
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Distributed in Missouri
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)