Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 14 Metered Doses, Rx Only, Manuf. for:
Summary
The FDA issued a Class III for Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, by Organon Llc. Reason: Defective Container.
Details
Source
Drug Recall
External ID
D-0551-2024
Action Date
2024-06-19
Status
Ongoing
Category
drug
Product Description
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 14 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-03
Lot/Code Info: Lot #: X024051, Exp 04/25/2025
Quantity Affected: 2,551 units
Reason for Recall
Defective Container
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-28
Company
Jersey City, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 49 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Organon Llc has 8 FDA actions in our database, including 3 recalls and 1 clearance.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Organon Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Organon Llc have FDA actions?
Organon Llc has 8 FDA actions in our database, including 3 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0551-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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