Park Avenue Compounding

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
4
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0178-2026Class IIFentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park AvenuSeptember 23, 2025
D-0200-2026Class IIPhenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 ParkSeptember 17, 2025