Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando,
Summary
The FDA issued a Class II for Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for by Ingenus Pharmaceuticals Llc. Reason: Out of specification for related substances (impurities)..
Details
Source
Drug Recall
External ID
D-0010-2023
Action Date
2022-10-26
Status
Completed
Category
drug
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
Lot/Code Info: Lot #: 22E040 Exp. 07/2023; 22F038 Exp. 08/2023
Quantity Affected: 6176 bottles
Reason for Recall
Out of specification for related substances (impurities).
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-30
Company
Orlando, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 16 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Ingenus Pharmaceuticals Llc has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ingenus Pharmaceuticals Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ingenus Pharmaceuticals Llc have FDA actions?
Ingenus Pharmaceuticals Llc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0010-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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