Park Avenue Compounding

FDA Regulatory Profile

Park Avenue Compounding appears in FDA public data with 2 recalls, 0 510(k) clearances, 5 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0178-2026, Class II) was initiated on September 23, 2025.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
5
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