FDA 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

Distribution

Distributed Nationwide in the USA and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2023-12-12

Report date

2024-01-03

Termination date

2024-09-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Durham, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0160-2024