US Drug Recall Register
Class II · Moderate risk Completed Initiated Sep 30, 2022 (4 years ago)

Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Out of specification for related substances (impurities).

What was recalled

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

Recalling firm
Ingenus Pharmaceuticals Llc
NDC code
50742-317-25
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0010-2023

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.