Drug recall D-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
Reason for recall
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Lots and codes
Lot #: 7Y9S. Exp June 2025
Recall details
- Recalling firm
- GlaxoSmithKline LLC, Durham, NC
- Quantity
- 67,508 inhalers
- Distribution
- Distributed Nationwide in the USA and Puerto Rico.
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 12, 2023
- Terminated
- September 12, 2024
Related products
- Anoro Ellipta – drug information
- NDC 0173-0869 Anoro Ellipta · Umeclidinium Bromide 62.5 ug/1; Vilanterol Trifenatate 25… · GlaxoSmithKline LLC