Drug recall
Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Rx Only…
FDA recall event 72800 · Class II · GlaxoSmithKline, LLC
Key facts
| Event ID | 72800 |
|---|---|
| Recall numbers | D-0519-2016 |
| Recalling firm | GlaxoSmithKline, LLC |
| Product type | Drugs |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Dec 3, 2015 |
| Report date | Dec 16, 2015 |
| Termination date | Oct 25, 2016 |
| City | Zebulon |
| State | NC |
| Country | United States |
| FEI number | 1033964 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: