← FDA ENFORCEMENT
D-0550-2024Class III

Organon Llc

Recalling firm
Organon Llc
Product type
Drug
Status
Ongoing
Report date
2024-06-19
Distribution
Nationwide in the USA
Firm state
NJ
Product quantity
2,886 units
Initiated by
Voluntary: Firm initiated
Reason for recall

Defective Container

Product description

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

Code / lot info

Lot #: X025346, Exp 3/3/2025

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.