Reported Jan 3, 2024 · Terminated

ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters…

GlaxoSmithKline LLC

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GlaxoSmithKline LLC · 410 Blackwell St · Durham, NC · 27701-3986

Is this the product you have?

  • 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
Lot codes and dates
  • Lot #: 7Y9S. Exp June 2025
Amount recalled
67,508 inhalers

Where it was sold

  • Nationwide
  • PR

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 12, 2024 · Data as of Sep 19, 8:05 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.