FDAClass IIOctober 26, 2022

Flunisolide Nasal Solution recall: Impurity Out of Spec

Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408; NDC…

Why was Flunisolide Nasal Solution recalled?

Out of specification for related substances (impurities).

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 22E040 Exp. 07/2023; 22F038 Exp. 08/2023

Product
Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408; NDC…
Recalling firm
Ingenus Pharmaceuticals Llc
Quantity
6176 bottles
Distribution
Nationwide within the United States
Recall date
October 26, 2022
Classification
Class II
Status
Completed
Agency
FDA (drug)
Open FDA enforcement record Latest recalls