Why it was recalled
Defective Container
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 numbers, UPCs & expiration codes
Lot #: X024051, Exp 04/25/2025
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0551-2024
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- May 28, 2024
- FDA report date
- Jun 19, 2024
- Quantity
- 2,551 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Organon Llc
Original FDA data
Every field from FDA enforcement report D-0551-2024, exactly as published.
Show all FDA fields
- City
- Jersey City
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94703
- Address
- 30 Hudson St Fl 33
- Code information
- Lot #: X024051, Exp 04/25/2025
- Postal code
- 07302-4804
- Report date
- Jun 19, 2024
- Product type
- Drugs
- Recall number
- D-0551-2024
- Classification
- Class III
- Recalling firm
- Organon Llc
- Product quantity
- 2,551 units
- Reason for recall
- Defective Container
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 28, 2024
- Initial firm notification
- Letter
- Center classification date
- Jun 10, 2024