D-0793-2017 Class II Ongoing
FDA drug recall D-0793-2017 was initiated by GlaxoSmithKline, LLC on May 16, 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: 562,883.
Recall details
- Product Type
- Drugs
- Report Date
- May 31, 2017
- Initiation Date
- May 16, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 562,883
Product description
Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, 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 US and Puerto Rico
Code information
Lot#: 7ZP0634, 7ZP0810, 7ZP0990, Exp. 5/18
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0793-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026