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

FDA recall notice · announced January 3, 2024 · Glaxosmithkline

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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

Reason for recall

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

Notes

Distribution: Distributed Nationwide in the USA and Puerto Rico.
Lot/code information: Lot #: 7Y9S. Exp June 2025
Quantity: 67,508 inhalers
Status: Terminated
Products in this recall event:
- 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- (D-0160-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.