Class III

Drug Recall: 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

GlaxoSmithKline LLC · December 12, 2023

Reason for Recall

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

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

Distribution

Distributed Nationwide in the USA and Puerto Rico.

States Affected

NATIONWIDE

Quantity Affected

67,508 inhalers

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0160-2024

Status: terminated

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.