Recalls / Class III
Class IIID-0550-2024
Product
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 60 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-02
- Brand name
- Asmanex
- Generic name
- Mometasone Furoate
- Active ingredient
- Mometasone Furoate
- Route
- Respiratory (inhalation)
- NDCs
- 78206-114, 78206-115
- FDA application
- NDA021067
- Affected lot / code info
- Lot #: X025346, Exp 3/3/2025
Why it was recalled
Defective Container
Recalling firm
- Firm
- Organon Llc
- Manufacturer
- Organon LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 30 Hudson St Fl 33, N/A, Jersey City, New Jersey 07302-4804
Distribution
- Quantity
- 2,886 units
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-05-28
- FDA classified
- 2024-06-10
- Posted by FDA
- 2024-06-19
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0550-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.