Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 30 Metered Doses...

FDA Recall #D-0552-2024 — Class III — May 28, 2024

Recall #D-0552-2024 Date: May 28, 2024 Classification: Class III Status: Ongoing

Product Description

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

Reason for Recall

Defective Container

Recalling Firm

Organon Llc — Jersey City, NJ

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Distribution

Nationwide in the USA

Code Information

Lot #: Y000085, Exp 4/25/2025

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated