# FDA recall D-0160-2024

> **GlaxoSmithKline LLC** · Class III · drug recall initiated 2023-12-12.

## 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

## Reason for recall

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

## Distribution

Distributed Nationwide in the USA and Puerto Rico.

## Key facts

- **Recall number:** D-0160-2024
- **Recalling firm:** GlaxoSmithKline LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-12-12
- **Report date:** 2024-01-03
- **Termination date:** 2024-09-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Durham, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0160-2024

## Citation

> AI Analytics. FDA recall D-0160-2024. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/D-0160-2024. Source: US FDA. Licensed CC0.

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