# FDA recall D-064-2013

> **GlaxoSmithKline, LLC.** · Class III · drug recall initiated 2012-10-24.

## Product

Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered Actuations, For Oral Inhalation with Advair HFA actuator only, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0715-20.

## Reason for recall

Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.

## Distribution

Nationwide and Puerto Rico.

## Key facts

- **Recall number:** D-064-2013
- **Recalling firm:** GlaxoSmithKline, LLC.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-10-24
- **Report date:** 2012-12-05
- **Termination date:** 2014-09-11

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-064-2013

## Citation

> AI Analytics. FDA recall D-064-2013. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-064-2013. Source: US FDA. Licensed CC0.

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