UPDATED: GlaxoSmithKline Recalling Ventolin Inhalers for Possible Package Leakage

The Asthma and Allergy Foundation of America is a non-profit organization and we are reporting this recall to inform people with asthma who rely on this medication.

If you have questions, call the GlaxoSmithKline response center, the manufacturer of Ventolin: 1-888-825-5249.

Note: As of May 16, 2017, GlaxoSmithKline expanded their recall. Additional lot numbers have been added below.

GlaxoSmithKline (GSK) issued a voluntary Class II recall on April 4, 2017 for three lots of Ventolin® HFA 200D Inhalers from U.S. hospitals, pharmacies, retailers and wholesalers as a precautionary measure. It is not a consumer recall.

The lot numbers are:

  • 6ZP0003 - expires April 2018
  • 6ZP9944 - expires April 2018
  • 6ZP9848 - expires March 2018
  • 7ZP0634 - expires May 2018
  • 7ZP0810 - expires May 2018
  • 7ZP0990 - expires May 2018

A GSK spokesman spoke with AAFA and said the recall is due to some complaints about the overwrap, or pouches containing the inhalers, becoming inflated by leaking from the product. The leaking may cause the inhaler to deliver fewer doses than shown on the dose counter. 

Patients are not being told to return the inhalers. If you have a question, call the company’s response center: 1-888-825-5249.

A Class II recall is one where “use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” according to the U.S. Food and Drug Administration.

The company released a statement that said, “Though the overall benefit-risk assessment for Ventolin® HFA 200D Inhaler when used at prescribed doses remains favourable, in this situation, there is possible risk to patients of experiencing diminished bronchodilation in the setting of acute bronchospasm if reliant on a rescue inhaler that could potentially not deliver the stated number of actuations. GSK is committed to supplying high quality product and patient satisfaction, and we sincerely regret any inconvenience this recall may cause."

If you need to fill a prescription for Ventolin HFA 200D, the voluntary recall should not affect pharmacy supplies.

Originally posted on April 5, 2017

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@Concerned, I hear your frustration about being on a fixed income. 

The Asthma and Allergy Foundation of America is not associated with GlaxoSmithKline who is the manufacturer of the Ventolin inhaler. We are  a non-profit organization, and we are reporting this recall to inform people with asthma who rely on this medication.

Please call GlaxoSmithKline's response center at 1-888-825-5249 and speak to their representative.

AAFA's blog post about What to Do If You Can't Afford Your Asthma Medicines can give you some tips on how to lower the cost of your asthma medications.

I am very, very frustrated and distraught with GlaxoSmithKline right now. If this is a problem, no matter how remote or minute, shouldn't the customer be able to return the product for a new product immediately? If not, why even bring it to our attention? I have contacted my pharmacy, my husband's pharmacy, my doctor and my husband's doctor and they know very little if anything about this recall. This is not something to guess about. IT IS MY LIFE..AND OTHERS... GSK needs to do a better job...and THEY (GSK) NEED TO INFORM THE RIGHT PEOPLE BEFORE THEY INFORM THE NEWS MEDIA!!!!!!!!!!!!

Hi @Shellz72,

Do you have an inhaler that matches the lot numbers? If so, it is okay to continue using the inhaler, but be aware that your inhaler may have leaked and so there may not be the full number of "puffs" available. You can call the company at  1-888-825-5249 for more information.

You may also want to call your doctor or insurance company about getting a new refill.

K8sMom2002 posted:

Hugs, Donna! I do hope you have a hands-free option so you're not getting a crick in the neck. I know that I've read where they are expecting higher than usual call volume. Is there any way to leave a message or email?

I finally got through and will check numbers on my husbands inhaler when I get home. Thanks for responding

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