# FDA recall D-0626-2017

> **GlaxoSmithKline, LLC** · Class II · drug recall initiated 2017-03-22.

## Product

Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC  22709, NDC 0173-0682-20.

## Reason for recall

Defective Delivery System: Elevated number of units with out of specification results for leak rate.

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-0626-2017
- **Recalling firm:** GlaxoSmithKline, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2017-03-22
- **Report date:** 2017-04-12

- **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-0626-2017

## Citation

> AI Analytics. FDA recall D-0626-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0626-2017. Source: US FDA. Licensed CC0.

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