Recalls / Class II
Class IID-0178-2026
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.
- Affected lot / code info
- Lot # 20250507-01D93C, Exp Date: 11-04-2025
Why it was recalled
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Recalling firm
- Firm
- Park Avenue Compounding
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3662 Park Ave Ste 140, Saint Louis, Missouri 63110-2512
Distribution
- Quantity
- 189 bags
- Distribution pattern
- Distributed in Missouri
Timeline
- Recall initiated
- 2025-09-23
- FDA classified
- 2025-11-20
- Posted by FDA
- 2025-11-26
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0178-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.