Recalls / Class II
Class IID-0480-2021
Product
Arnuity Ellipta (fluticasone furoate inhalation powder) 200 mcg 1 Ellipta Inhaler containing 1 Foil Strip of 30 Blisters Rx Only NDC 0173-0876-10 GlaxoSmithKline Research Triangle Park, NC 27709
- Brand name
- Arnuity Ellipta
- Generic name
- Fluticasone Furoate
- Active ingredient
- Fluticasone Furoate
- Route
- Respiratory (inhalation)
- NDCs
- 0173-0874, 0173-0888, 0173-0876
- FDA application
- NDA205625
- Affected lot / code info
- 5U3D
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- GlaxoSmithKline LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 353 inhalers
- Distribution pattern
- FL, GA, SC
Timeline
- Recall initiated
- 2021-03-15
- FDA classified
- 2021-05-24
- Posted by FDA
- 2021-06-02
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0480-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.