D-0178-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- November 26, 2025
- Initiation Date
- September 23, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 189 bags
Product Description
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 Pattern
Distributed in Missouri
Code Information
Lot # 20250507-01D93C, Exp Date: 11-04-2025