Recalls / Class III
Class IIID-0160-2024
Product
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
- Brand name
- Anoro Ellipta
- Generic name
- Umeclidinium Bromide And Vilanterol Trifenatate
- Active ingredients
- Umeclidinium Bromide, Vilanterol Trifenatate
- Route
- Respiratory (inhalation)
- NDC
- 0173-0869
- FDA application
- NDA203975
- Affected lot / code info
- Lot #: 7Y9S. Exp June 2025
Why it was recalled
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Recalling firm
- Firm
- GlaxoSmithKline LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 410 Blackwell St, Durham, North Carolina 27701-3986
Distribution
- Quantity
- 67,508 inhalers
- Distribution pattern
- Distributed Nationwide in the USA and Puerto Rico.
Timeline
- Recall initiated
- 2023-12-12
- FDA classified
- 2023-12-22
- Posted by FDA
- 2024-01-03
- Terminated
- 2024-09-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0160-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.