FDA-Drug2022-10-26Class II

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

Ingenus Pharmaceuticals Llc
Hazard

Out of specification for related substances (impurities).

Sold states
Nationwide within the United States
Affected count
6176 bottles
Manufactured in
4190 Millenia Blvd, N/A, Orlando, FL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0010-2023

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