Why it was recalled
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
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.
Lot numbers, UPCs & expiration codes
Lot # 20250507-01D93C, Exp Date: 11-04-2025
Where it was sold
Distributed in Missouri
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0178-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 23, 2025
- FDA report date
- Nov 26, 2025
- Quantity
- 189 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Park Avenue Compounding
Original FDA data
Every field from FDA enforcement report D-0178-2026, exactly as published.
Show all FDA fields
- City
- Saint Louis
- State
- MO
- Status
- Ongoing
- Country
- United States
- Event ID
- 97938
- Address
- 3662 Park Ave Ste 140
- Code information
- Lot # 20250507-01D93C, Exp Date: 11-04-2025
- Postal code
- 63110-2512
- Report date
- Nov 26, 2025
- Product type
- Drugs
- Recall number
- D-0178-2026
- Classification
- Class II
- Recalling firm
- Park Avenue Compounding
- Product quantity
- 189 bags
- Reason for recall
- CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Distributed in Missouri
- Recall initiation date
- Sep 23, 2025
- Initial firm notification
- Letter
- Center classification date
- Nov 20, 2025