Class III Recall

GlaxoSmithKline LLC

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
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Classification
Class III
Status
Terminated
Lot
Lot #: 7Y9S. Exp June 2025
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.