Eugia US LLC

FDA Regulatory Profile

Summary

Total Recalls
16 (1 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0472-2025Class IIGentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx OnMay 29, 2025
D-0389-2025Class IITirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx onApril 21, 2025
D-0390-2025Class IITirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), RxApril 21, 2025
D-0363-2025Class IITestosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, DistributApril 10, 2025
D-0186-2025Class IIProgesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in InDecember 27, 2024
D-0185-2025Class IImedroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose VialDecember 18, 2024
D-0624-2024Class IIProgesterone Injection, USP, 500 mg per 10 mL (50mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Mfd. in July 26, 2024
D-0555-2024Class IIDexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx May 23, 2024
D-0556-2024Class IIIEptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India for: AuroMeMay 22, 2024
D-0385-2024Class IITobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHFebruary 22, 2024
D-0390-2024Class IINicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed February 20, 2024
D-0391-2024Class IINicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedicsFebruary 20, 2024
D-0366-2024Class IIMethylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose ViaFebruary 20, 2024
D-0440-2024Class IMethocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial packed 25 vials per carFebruary 15, 2024
D-0041-2024Class IITriamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL Multiple Dose September 28, 2023
D-0095-2023Class IIAcyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only, DistribuDecember 28, 2022