Drug & medication recalls Moderate risk

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

Recall date
September 30, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0010-2023
FDA classification
Class II
Brand / firm
Ingenus Pharmaceuticals Llc
Sold / distributed
Nationwide within the United States

Why it was recalled

Out of specification for related substances (impurities).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

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

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