FDA Recall D-0551-2024
Organon Llc · Jersey City, NJ
Class III Ongoing 716 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
Product
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
Reason for recall
Defective Container
Recall record
- Recall number
D-0551-2024- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2024-05-28
- Classified by FDA Center
- 2024-06-10
- FDA published
- 2024-06-19
- Recalling firm
- Organon Llc
- Firm location
- Jersey City, NJ
Drug identification
- Brand name(s)
- ASMANEX
- Generic name(s)
- MOMETASONE FUROATE
- Manufacturer(s)
- Organon LLC
- NDC(s)
78206-114, 78206-115- Route(s)
- RESPIRATORY (INHALATION)
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.