D-0793-2017 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- May 31, 2017
- Initiation Date
- May 16, 2017
- Termination Date
- N/A
- 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