Recalling firm
Park Avenue Compounding
Product type
Drug
Status
Ongoing
Report date
2025-11-26
Distribution
Distributed in Missouri
Firm state
MO
Product quantity
189 bags
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
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.
Code / lot info
Lot # 20250507-01D93C, Exp Date: 11-04-2025
Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.