Recalls / Class II
Class IID-0481-2021
Product
TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMEDIDINIUM AND VILANTEROL INHALATION POWDER) 100-62.5-25MCG 60; NDC/UPC 0173-0893-10; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
- 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
- FN2J
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
- 4065 CARTON
- 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-0481-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.