Recalls / Class III

Class IIID-0552-2024

Product

Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 30 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-0114-04

Affected lot / code info

Lot #: Y000085, Exp 4/25/2025

Why it was recalled

Defective Container

Recalling firm

Firm

Organon Llc

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

30 Hudson St Fl 33, N/A, Jersey City, New Jersey 07302-4804

Distribution

Quantity

0

Distribution pattern

Nationwide in the USA

Timeline

Recall initiated

2024-05-28

FDA classified

2024-06-10

Posted by FDA

2024-06-19

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0552-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.