PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: November 26, 2025 Initiated: September 23, 2025 #D-0178-2026

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.

Reason for Recall

CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.

Details

Recalling Firm
Park Avenue Compounding
Units Affected
189 bags
Distribution
Distributed in Missouri
Location
Saint Louis, MO

Frequently Asked Questions

What product was recalled?
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.. Recalled by Park Avenue Compounding. Units affected: 189 bags.
Why was this product recalled?
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 26, 2025. Severity: Moderate. Recall number: D-0178-2026.