Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalatio...
FDA Recall #D-0519-2016 — Class II — December 3, 2015
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.
Recalling Firm
GlaxoSmithKline, LLC — Zebulon, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
128,704 Inhalers
Distribution
MS and VT
Code Information
Lot #s: 5ZP1708, Exp. 12/2016; 5ZP1951, Exp. 02/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated