D-0626-2017 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- April 12, 2017
- Initiation Date
- March 22, 2017
- Termination Date
- N/A
- 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.