FDA Drug recall D-0178-2026
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 Loui…
- FDA Drug
- Class II
- ongoing
- Published 2025-11-26
On 2025-11-26 the FDA classified a Class II recall of 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 Loui… by Park Avenue Compounding, citing CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0178-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-23 |
| Published | 2025-11-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Park Avenue Compounding |
| Distribution | MO |
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
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Identifiers
| code_info | Lot # 20250507-01D93C, Exp Date: 11-04-2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0178-2026%22
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