Nephron Sc Inc

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
0
Inspections
19
Compliance Actions
5

Recent Recalls

NumberClassProductDate
D-0364-2023Class IISterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street ExtenFebruary 23, 2023
D-0175-2023Class IIAsthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine, USP 11.25), 30x0.5 mL January 13, 2023
D-0176-2023Class IIS2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Sterile Unit-of-Use Vials January 13, 2023
D-0178-2023Class IISterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 xJanuary 12, 2023
D-0177-2023Class II0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron PharmaceuticJanuary 12, 2023
D-1354-2022Class IIKetorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx August 10, 2022