D-0793-2017 Class II Ongoing

Recalled by GlaxoSmithKline, LLC — Zebulon, NC

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