FDA recall D-0178-2026

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.

Reason for recall

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

Distribution

Distributed in Missouri

Key facts

Status

Ongoing

Initiation date

2025-09-23

Report date

2025-11-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Louis, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0178-2026