Inhub Wixela 500/50MCG recalled over manufacturing violations

Recall date

January 26, 2022

Source

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

Official notice title

CARDINAL HEALTHCARE recalls Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 500/50MCG, 60 Doses of Inhalation Powder, M…

Recall number

D-0202-2024

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

Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 500/50MCG, 60 Doses of Inhalation Powder, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-9320-32