GlaxoSmithKline LLC: Drug Recall

Recall Details

Recall Number

D-0160-2024

Classification

Class III

Product Type

Drug

Recalling Firm

GlaxoSmithKline LLC

Status

Terminated

Date Initiated

12/12/2023

Location

Durham, NC, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

67,508 inhalers

Reason for Recall

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

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

Distribution Pattern

Distributed Nationwide in the USA and Puerto Rico.

Other Recalls by GlaxoSmithKline LLC

• Class III: Low Risk 05/17/2024
  Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.
• Class III: Low Risk 05/13/2022
  Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.

View all recalls by GlaxoSmithKline LLC →