FDA recall D-0551-2024

Organon Llc · Class III · drug

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

Distribution

Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2024-05-28
Report date
2024-06-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Jersey City, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0551-2024