ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters
Summary
The FDA issued a Class III for ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 by GlaxoSmithKline LLC. Reason: Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification.
Details
Source
Drug Recall
External ID
D-0160-2024
Action Date
2024-01-03
Status
Terminated
Category
drug
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
Lot/Code Info: Lot #: 7Y9S. Exp June 2025
Quantity Affected: 67,508 inhalers
Reason for Recall
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Distribution
Distributed Nationwide in the USA and Puerto Rico.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-12
Company
Durham, NC
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 74 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
GlaxoSmithKline LLC has 10 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GlaxoSmithKline LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GlaxoSmithKline LLC have FDA actions?
GlaxoSmithKline LLC has 10 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0160-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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