FDA-Drug2024-01-03Class III

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

GlaxoSmithKline LLC
Hazard

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

Sold states
Distributed Nationwide in the USA and Puerto Rico.
Affected count
67,508 inhalers
Manufactured in
410 Blackwell St, Durham, NC, United States
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 0173-0869-10

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0160-2024

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