GlaxoSmithKline Recalls Ventolin HFA Inhalers

GlaxoSmithKline is voluntarily recalling Ventolin HFA (albuterol sulfate) Inhalation Aerosol (rescue inhalers) 90 mcg per actuation, 200 Metered inhalations. 

Reason for Recall: The reason for the recall is defective delivery system. Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.

The voluntary retail-level recall affects only two lots of Ventolin HFA. The recall does not extend beyond the US. 

The lot numbers 5ZP1708 and 5ZP1951, which were distributed only in the US market. Please note that lot number 5ZP1708 was manufactured on 07 July 2015, with an expiration date of December 2016. Lot 5ZP1951 was manufactured on 22 August 2015 with an expiration date of February 2017.

• No other lots are affected by the voluntary recall, meaning that, regardless of expiration date or doses indicated in dose counters, only inhalers in these two lots are affected.
• People with inhalers that match the expiration date on the Ventolin HFA inhaler, but not the lot number, are not impacted by the recall.
• People should call their pharmacy and/or doctor to ask about getting a new inhaler.

Questions regarding a Ventolin HFA recall, contact GSK’s Customer Service Center at 1-888-825-5249, Monday-Friday, 8:30 am - 5:30 pm ET.  

For more information go to  FDA website

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