FDA Drug Class III — Least Serious

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

Hazard

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

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Products

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
Brand
GlaxoSmithKline LLC
UPC
Lot #: 7Y9S. Exp June 2025

Units Affected

67,508 inhalers

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