Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 500/50MCG, 60 Doses ...
FDA Recall #D-0202-2024 — Class II — January 26, 2022
Product Description
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
Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recalling Firm
CARDINAL HEALTHCARE — Dublin, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1 unit
Distribution
Nationwide USA
Code Information
Batch 62002532
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated