Class IIIOngoing

Asmanex Twisthaler recall

FDA recall D-0552-2024 · initiated May 28, 2024

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

Why it was recalled

Defective Container

Details

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
Recalling company: Organon USA LLC
Classification: Class III
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA
Initiated: May 28, 2024
FDA report date: Jun 19, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0552-2024 ↗

← All drug recalls