# FDA recall D-0519-2016

> **GlaxoSmithKline, LLC** · Class II · drug recall initiated 2015-12-03.

## Product

Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Rx Only, For Oral Inhalation Only, Net Wt. 18 g, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20

## Reason for recall

Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.

## Distribution

MS and VT

## Key facts

- **Recall number:** D-0519-2016
- **Recalling firm:** GlaxoSmithKline, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-12-03
- **Report date:** 2015-12-16
- **Termination date:** 2016-10-25

- **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-0519-2016

## Citation

> AI Analytics. FDA recall D-0519-2016. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0519-2016. Source: US FDA. Licensed CC0.

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