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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93565

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 12, 2023
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
GlaxoSmithKline LLC

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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
Recall number
D-0160-2024
Initiated
December 12, 2023
Classification
Class III
Status
Terminated
Recalling firm
GlaxoSmithKline LLC
Quantity
67,508 inhalers

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out of Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.