Recall
FDAHealthSeptember 23, 2025

Park Avenue Compounding — 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.

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

Is this relevant to me?

Geography
Unknown
Source agency
FDA
Category
Health
Published
September 23, 2025

Distributed in Missouri

What's affected?

Product
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.
Lot code
20250507-01D93C

Additional details

Lot # 20250507-01D93C, Exp Date: 11-04-2025

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 189 bags.

View original FDA notice →

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