Park Avenue Compounding recalls fentanyl citrate and ropivacaine bags over manufacturing quality rule deviations
The notice says the 150 mL bags of fentanyl citrate 2 mcg / ml and ropivacaine 0.2% in NS were made with deviations from current good manufacturing practice, tied to a revised reading of quality level results.
What to do
The notice does not give instructions. Read the official notice for details.
Recall details
- 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.
- Company
- Park Avenue Compounding
- Hazard
- CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
- Units
- 189 bags
- Where sold
- Distributed in Missouri
- FDA classification
- Class II · Ongoing
- Classified by FDA
- November 20, 2025
- Recall started
- September 23, 2025
- FDA enforcement report
- November 26, 2025
- Identifiers
- Codes: Lot # 20250507-01D93C, Exp Date: 11-04-2025
- FDA recall number: D-0178-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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.
- Classification
- Class II (Ongoing)
- Distribution
- Distributed in Missouri
- Quantity
- 189 bags
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