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 & QualificationReason 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
Other recalls SPEQ maps to Validation & Qualification
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.