D-0519-2016 Class II Terminated
FDA drug recall D-0519-2016 was initiated by GlaxoSmithKline, LLC on Dec 3, 2015 and is designated Class II. 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. The recall status is terminated (terminated Oct 25, 2016). Affected quantity: 128,704 Inhalers.
Recall details
- Product Type
- Drugs
- Report Date
- Dec 16, 2015
- Initiation Date
- Dec 3, 2015
- Termination Date
- Oct 25, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 128,704 Inhalers
Product description
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 pattern
MS and VT
Code information
Lot #s: 5ZP1708, Exp. 12/2016; 5ZP1951, Exp. 02/2017
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0519-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026