FDA Recall D-0178-2026
Park Avenue Compounding · Saint Louis, MO
Class II Ongoing 233 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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.
Recall record
- Recall number
D-0178-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Distributed in Missouri
- Recall initiated
- 2025-09-23
- Classified by FDA Center
- 2025-11-20
- FDA published
- 2025-11-26
- Recalling firm
- Park Avenue Compounding
- Firm location
- Saint Louis, MO
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.