FDA-Drug2025-11-26Class IIPROCESSING DEFECT
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.
Hazard
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Intended for
Adults
Illnesses reported
None reported
Sold states
Distributed in Missouri
Affected count
189 bags
Manufactured in
3662 Park Ave Ste 140, Saint Louis, MO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0178-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.