Ventolin Aerosol, Metered
FDA Recall NDC 0173-0682

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 4 recorded enforcement report(s) associated with Ventolin (NDC 0173-0682). A significant event, classified as Class II, was initiated on May 16, 2017 by Glaxosmithkline Llc. The reported reason for this action was: "Defective Delivery System: Elevated number of units with out of specification results for leak rate"

This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.

Reported Recall Events

D-0793-2017ONGOINGD-0626-2017ONGOINGD-0519-2016TERMINATEDD-1666-2012TERMINATED

May 2017 Class II Recall: Defective Delivery System

Recall Number
D-0793-2017
Class II Ongoing
Reason for Recall
Defective Delivery System: Elevated number of units with out of specification results for leak rate
Initiated
May 16, 2017
Reported
May 31, 2017
Quantity
562,883

Recall Profile & Regulatory Data

Event ID
77329
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
GlaxoSmithKline, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US and Puerto Rico
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.
Batch or Lot Expiration Information
Lot# : 7ZP0634, 7ZP0810, 7ZP0990, Exp. 5/18
Affected Packages Involved in this Recall
0173-0682-20Product
0173-0682-24Product

March 2017 Class II Recall: Defective Delivery System

Recall Number
D-0626-2017
Class II Ongoing
Reason for Recall
Defective Delivery System: Elevated number of units with out of specification results for leak rate.
Initiated
Mar 22, 2017
Reported
Apr 12, 2017
Quantity
593,088 inhalers

Recall Profile & Regulatory Data

Event ID
76839
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
GlaxoSmithKline, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Product Description
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.
Batch or Lot Expiration Information
Lot# : 6ZP9848, Exp 03/18; 6ZP0003, 6ZP9944, Exp 04/18.
Affected Packages Involved in this Recall
0173-0682-20Product
0173-0682-24Product

December 2015 Class II Recall: Defective Delivery System

Recall Number
D-0519-2016
Class II Terminated
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.
Initiated
Dec 03, 2015
Reported
Dec 16, 2015
Quantity
128,704 Inhalers

Recall Profile & Regulatory Data

Event ID
72800
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
GlaxoSmithKline, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
MS and VT
Termination Date
Oct 25, 2016
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
Batch or Lot Expiration Information
Lot# s: 5ZP1708, Exp. 12/2016; 5ZP1951, Exp. 02/2017
Affected Packages Involved in this Recall
0173-0682-20Product
0173-0682-24Product

July 2012 Class II Recall: Does Not Deliver Proper Metered Dose

Recall Number
D-1666-2012
Class II Terminated
Reason for Recall
Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.
Initiated
Jul 26, 2012
Reported
Sep 05, 2012
Quantity
1,412,566 inhalers

Recall Profile & Regulatory Data

Event ID
62799
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
GlaxoSmithKline Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 04, 2014
Product Description
Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL INHALATION ONLY - For use with Ventolin HFA actuator only. Net. wt. 18 g Rx only, GlaxoSmithKline, Reasearch Triangle Park, NC 27709 NDC 0173-0682-20
Batch or Lot Expiration Information
Lot# Lot 1ZP7355 Exp. 01/13, 1ZP7749 Exp. 01/13, 1ZP8141 Exp. 01/13, 1ZP8147 Exp. 01/13, 1ZP7729 Exp. 01/13, 1ZP0414 Exp. 03/13, 1ZP0464 Exp. 03/13, 1ZP0570 Exp. 03/13, 1ZP0576 Exp. 03/13, 1ZP0919 Exp. 03/13, 2ZP4959 Exp. 04/13, 2ZP4966 Exp. 04/13
Affected Packages Involved in this Recall
0173-0682-20Product
0173-0682-24Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.