December 2023 FDA Recall Anoro Ellipta by Glaxosmithkline Llc
D-0160-2024 - Failed Release Testing
This Class III drug recall was voluntarily initiated by Glaxosmithkline Llc on December 12, 2023 for the product Anoro Ellipta. The FDA reported the reason for recall as failed release testing. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0160-2024
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
12-12-2023
01-03-2024
67,508 inhalers
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
GlaxoSmithKline LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed Nationwide in the USA and Puerto Rico.
09-12-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : 7Y9S. Exp June 2025
