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

FDA Recall #D-0010-2023 — Class II — September 30, 2022

Recall #D-0010-2023 Date: September 30, 2022 Classification: Class II Status: Completed

Product Description

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

Reason for Recall

Out of specification for related substances (impurities).

Recalling Firm

Ingenus Pharmaceuticals Llc — Orlando, FL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

6176 bottles

Distribution

Nationwide within the United States

Code Information

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

Status

Completed

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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