Drug 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.
D-0178-2026
Product summary
- Event
- Event 97938
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 189 bags
- Official record key
drug-enforcement:D-0178-2026
Official wording
Reason: CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Code information: Lot # 20250507-01D93C, Exp Date: 11-04-2025
Distribution pattern: Distributed in Missouri
Derived failure modes
-
Manufacturing or process control
CGMP Deviations