FDA-Drug2021-06-02Class II

Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder) 100 mcg/62.5 mcg/25 mcg; 1 ELLIPTA Inhaler containing 30 doses (60 blisters total) Rx Only NDC 0173-0887-10 GlaxoSmithKline Research Triangle Park, NC 27709

Cardinal Health Inc.
Hazard

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Sold states
FL, GA, SC
Affected count
903 inhalers
Manufactured in
7000 Cardinal Pl, N/A, Dublin, OH, United States
Products
Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder) 100 mcg/62.5 mcg/25 mcg; 1 ELLIPTA Inhaler containing 30 doses (60 blisters total) Rx Only NDC 0173-0887-10 GlaxoSmithKline Research Triangle Park, NC 27709

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0482-2021

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