Drug Enforcement D-0160-2024

Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification

Status

Terminated

Classification

Class III

Report Date

January 3, 2024

Termination Date

September 12, 2024

Product Information

Product description
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
Product quantity
67,508 inhalers
Reason for recall
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Distributed Nationwide in the USA and Puerto Rico.

Location & Firm

Recalling firm
GlaxoSmithKline LLC
Address
410 Blackwell St

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0160-2024
Event ID
93565
Recall initiation date
December 12, 2023
Center classification date
December 22, 2023
Code info
Lot #: 7Y9S. Exp June 2025
More code info
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