D-0178-2026 Class II Ongoing

Recalled by Park Avenue Compounding — Saint Louis, MO

Recall Details

Product Type
Drugs
Report Date
November 26, 2025
Initiation Date
September 23, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
189 bags

Product Description

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.

Reason for Recall

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

Distribution Pattern

Distributed in Missouri

Code Information

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