Reported Oct 26, 2022 · Completed

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

Ingenus Pharmaceuticals LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ingenus Pharmaceuticals Llc · 4190 Millenia Blvd · Orlando, FL · 32839-6408

Is this the product you have?

  • Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only
  • Manufactured forIngenus Pharmaceuticals, LLC Orlando, FL 32839-6408; NDC 50742-317-25 UPC 3 50742 31725 7
Lot codes and dates
    • Lot #: 22E040 Exp. 07/2023
    • 22F038 Exp. 08/2023
Amount recalled
6176 bottles

Where it was sold

  • Nationwide

Why it was recalled

Out of specification for related substances (impurities).

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 5:49 PM UTC

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