Ingenus Pharmaceuticals Llc

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0010-2023Class IIFlunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus PharmaceutSeptember 30, 2022
D-0374-2022Class IIClobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDCJanuary 10, 2022
D-0146-2020Class IILeucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 ROctober 9, 2019
D-1058-2019Class IIIDiclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: March 18, 2019
D-0890-2018Class IIIrinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only,June 8, 2018
D-0891-2018Class IIIrinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, June 8, 2018