D-0519-2016 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 16, 2015
- Initiation Date
- December 3, 2015
- Termination Date
- October 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