← FDA ENFORCEMENT
D-0550-2024Class III
Organon Llc
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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. 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. Open the enforcement explorer →