Drug recall D-0010-2023

Class II Completed reported Oct 26, 2022

Product

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).

Lots and codes

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

Recall details

Recalling firm
Ingenus Pharmaceuticals Llc, Orlando, FL
Quantity
6176 bottles
Distribution
Nationwide within the United States
Type
Voluntary: Firm initiated
Recall initiated
September 30, 2022

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