D-0626-2017 Class II Ongoing
FDA drug recall D-0626-2017 was initiated by GlaxoSmithKline, LLC on Mar 22, 2017 and is designated Class II. Reason for recall: Defective Delivery System: Elevated number of units with out of specification results for leak rate. The recall status is ongoing. Affected quantity: 593,088 inhalers.
Recall details
- Product Type
- Drugs
- Report Date
- Apr 12, 2017
- Initiation Date
- Mar 22, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 593,088 inhalers
Product description
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 pattern
Nationwide in the USA and Puerto Rico
Code information
Lot #: 6ZP9848, Exp 03/18; 6ZP0003, 6ZP9944, Exp 04/18.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0626-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026