Could cause temporary or reversible harm; serious harm is unlikely.
Defective Delivery System: Elevated number of units with out of specification results for leak rate.
| Brand name | VENTOLIN |
| Generic name | ALBUTEROL SULFATE |
| Active ingredient(s) | ALBUTEROL SULFATE |
| Distributed by / for | GlaxoSmithKline, LLC |
| NDC | 0173-0682-20 |
| Full product label | 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. |
| Recalling firm | GlaxoSmithKline, LLC |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 593,088 inhalers |
| Recall initiated | 2017-03-22 |
| Report date | 2017-04-12 |
| Recall completed | — |
| Recall number | D-0626-2017 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Zebulon NC United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗