Drug recall D-0626-2017

Class II Ongoing reported Apr 12, 2017

Product

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.

Lots and codes

Lot #: 6ZP9848, Exp 03/18; 6ZP0003, 6ZP9944, Exp 04/18.

Recall details

Recalling firm
GlaxoSmithKline, LLC, Zebulon, NC
Quantity
593,088 inhalers
Distribution
Nationwide in the USA and Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
March 22, 2017

Related products