← FDA ENFORCEMENT
D-0160-2024Class III

GlaxoSmithKline LLC

Recalling firm
GlaxoSmithKline LLC
Product type
Drug
Status
Terminated
Report date
2024-01-03
Distribution
Distributed Nationwide in the USA and Puerto Rico.
Firm state
NC
Product quantity
67,508 inhalers
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
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

Code / lot info

Lot #: 7Y9S. Exp June 2025

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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.