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.

Recall Number: D-0178-2026

Firm: Park Avenue Compounding

Classification: Class II

Status: Ongoing

Report Date: 20251126

Initiation Date: 20250923

Termination Date:

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

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.