Asmanex Twisthaler recalled over manufacturing violations

Recall date

January 26, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

CARDINAL HEALTHCARE recalls Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuation), 120 Metered Doses, Rx only, Manufactu…

Recall number

D-0169-2024

FDA classification

Class II

Brand / firm

CARDINAL HEALTHCARE

Sold / distributed

Nationwide USA

Why it was recalled

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuation), 120 Metered Doses, Rx only, Manufactured for: Organon LLC, a subsidiary of Organon & Co., Jersey City, NJ 07302; Manufactured by: MSD International GmbH (Singapore Branch) Singapore 638030, Singapore. NDC: 78206-114-01