Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408; NDC 50742-317-25 UPC 3 50742 31725 7

Recall Number: D-0010-2023

Firm: Ingenus Pharmaceuticals Llc

Classification: Class II

Status: Completed

Report Date: 20221026

Initiation Date: 20220930

Termination Date:

Out of specification for related substances (impurities).

Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408; NDC 50742-317-25 UPC 3 50742 31725 7