GlaxoSmithKline LLC recalls ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters…

Recall date

December 12, 2023

Source

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

Recall number

D-0160-2024

FDA classification

Class III

Brand / firm

GlaxoSmithKline LLC

Sold / distributed

Distributed Nationwide in the USA and Puerto Rico.

Why it was recalled

Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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