American Regent, Inc.

FDA Regulatory Profile

Summary

Total Recalls
8
510(k) Clearances
0
Inspections
36
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0494-2026Class IIILevocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx OApril 16, 2026
D-0398-2025Class IIniCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, April 18, 2025
D-0399-2025Class IIniCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, April 18, 2025
D-0080-2025Class IIVenofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose ViNovember 11, 2024
D-0082-2025Class IIVenofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose ViNovember 11, 2024
D-0081-2025Class IIVenofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-DoseNovember 11, 2024
D-0503-2024Class IIniCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx May 14, 2024
D-0507-2024Class IIVasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx onlyMay 13, 2024