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U.S. Department of Health and Human Services

Enforcement Report - Week of December 16, 2015

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Product Detail

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
Recall Number D-0519-2016
Classification Class II
Code Info Lot #s: 5ZP1708, Exp. 12/2016; 5ZP1951, Exp. 02/2017
Product Distributed Qty 128,704 Inhalers
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.

Event Detail

Event Id 72800
Product Type Drugs
Status Ongoing
Recalling Firm GlaxoSmithKline, LLC
City Zebulon
State NC
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2015-12-03
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern MS and VT
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