September 2022 FDA Recall Flunisolide by Ingenus Pharmaceuticals Llc (D-0010-2023 - Out of specification for related substances (impurities).)
This Class II drug recall was voluntarily initiated by Ingenus Pharmaceuticals Llc on September 30, 2022 for the product Flunisolide. The FDA reported the reason for recall as out of specification for related substances (impurities).. The product was distributed Nationwide and the recall is currently completed.
Recall Number: D-0010-2023
Out of specification for related substances (impurities).
09-30-2022
10-26-2022
6176 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Ingenus Pharmaceuticals Llc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : 22E040 Exp. 07/2023; 22F038 Exp. 08/2023
