Flunisolide Solution
FDA Recall NDC 50742-317
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Flunisolide (NDC 50742-317). A significant event, classified as Class II, was initiated on Sep 30, 2022 by Ingenus Pharmaceuticals, Llc. The reported reason for this action was: "Out of specification for related substances (impurities)."
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
September 2022 Class II Recall: Out of specification for related substances (impurities).
Recall Number
Class II Completed
Out of specification for related substances (impurities).
Sep 30, 2022
Oct 26, 2022
6176 bottles
Recall Profile & Regulatory Data
Event ID
90934
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Ingenus Pharmaceuticals Llc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
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
Batch or Lot Expiration Information
Lot# : 22E040 Exp. 07/2023; 22F038 Exp. 08/2023
Affected Packages Involved in this Recall
50742-317-25Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
