Anoro Ellipta Powder
FDA Recall NDC 0173-0869
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Anoro Ellipta (NDC 0173-0869). A significant event, classified as Class III, was initiated on Dec 12, 2023 by Glaxosmithkline Llc. The reported reason for this action was: "Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Dec 12, 2023
Jan 03, 2024
67,508 inhalers
Recall Profile & Regulatory Data
Event ID
93565
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
GlaxoSmithKline LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA and Puerto Rico.
Termination Date
Sep 12, 2024
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
Batch or Lot Expiration Information
Lot# : 7Y9S. Exp June 2025
Affected Packages Involved in this Recall
0173-0869-10Product
0173-0869-06Product
0173-0869-61Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
