Drug Enforcement D-0010-2023

Out of specification for related substances (impurities).

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Status

Completed

Classification

Class II

Report Date

October 26, 2022

Termination Date

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Product Information

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
Product quantity
6176 bottles
Reason for recall
Out of specification for related substances (impurities).
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
Ingenus Pharmaceuticals Llc
Address
4190 Millenia Blvd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0010-2023
Event ID
90934
Recall initiation date
September 30, 2022
Center classification date
October 17, 2022
Code info
Lot #: 22E040 Exp. 07/2023; 22F038 Exp. 08/2023
More code info
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