ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains...
FDA Recall #D-0160-2024 — Class III — December 12, 2023
Product Description
ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters total), Rx Only, Manufactured by GlaxoSmithKline Durham, NC 27701. NDC 0173-0869-10
Reason for Recall
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Recalling Firm
GlaxoSmithKline LLC — Durham, NC
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
67,508 inhalers
Distribution
Distributed Nationwide in the USA and Puerto Rico.
Code Information
Lot #: 7Y9S. Exp June 2025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated