# FDA recall D-0178-2026

> **Park Avenue Compounding** · Class II · drug recall initiated 2025-09-23.

## 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

- **Recall number:** D-0178-2026
- **Recalling firm:** Park Avenue Compounding
- **Classification:** Class II
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-0178-2026. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/D-0178-2026. Source: US FDA. Licensed CC0.

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