Drug recall D-0519-2016

Class II Terminated reported Dec 16, 2015

Product

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.

Lots and codes

Lot #s: 5ZP1708, Exp. 12/2016; 5ZP1951, Exp. 02/2017

Recall details

Recalling firm
GlaxoSmithKline, LLC, Zebulon, NC
Quantity
128,704 Inhalers
Distribution
MS and VT
Type
Voluntary: Firm initiated
Recall initiated
December 3, 2015
Terminated
October 25, 2016

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