Recalls / Class II
Class IID-0482-2021
Product
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
- Brand name
- Trelegy Ellipta
- Generic name
- Fluticasone Furoate, Umeclidinium Bromide And Vilanterol Trifenatate
- Active ingredients
- Fluticasone Furoate, Umeclidinium Bromide, Vilanterol Trifenatate
- Route
- Respiratory (inhalation)
- NDCs
- 0173-0887, 0173-0893
- FDA application
- NDA209482
- Affected lot / code info
- 3X8P
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
- 903 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-0482-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.