Drug 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
D-0160-2024
Product summary
- Event
- Event 93565
- Status
- Terminated
- Classification
- Class III
- Quantity
- 67,508 inhalers
- Official record key
drug-enforcement:D-0160-2024
Official wording
Reason: Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Code information: Lot #: 7Y9S. Exp June 2025
Distribution pattern: Distributed Nationwide in the USA and Puerto Rico.
Derived failure modes
-
Potency or specification failure
Out of Specification