GlaxoSmithKline Recalls Two Lots of Ventolin HFA Albuterol Sulfate Inhalers

 


GlaxoSmithKline voluntary recall of two lots of Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations

Product DescriptionVentolin 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 NumberD-0519-2016
ClassificationClass II
Code InfoLot #s: 5ZP1708, Exp. 12/2016; 5ZP1951, Exp. 02/2017
Product Distributed Qty128,704 Inhalers
Reason For RecallDefective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.

 

It is important to stay up-to-date on news about asthma and allergies. By joining our community and following our blog, you will be able to receive breaking news about research and treatments. Our community also provides an opportunity to connect with other patients who manage these conditions for peer support.


JOIN NOW


UPDATE from GlaxoSmithKline 2/19/16:
"In response to some of the questions raised on this forum, any person with concerns about this voluntary recall, or if you believe you have an inhaler from an affected lot, please contact the GSK Response Center for instructions. This call is free of charge.  The lot numbers affected by the recall are Lot 5ZP1708 and Lot 5ZP1951.

Please do not go directly to your pharmacy without calling the Response Center, as operators will have information on the voluntary recall and, if applicable, clear guidance for you on the return and free replacement process.  Pharmacists may also call in if they have questions.  The phone number is 1-888-825-5249, Monday-Friday, 8:30 am - 5:30 pm ET. There is no charge for this call."

Add Comment

Comments (27)

Newest · Oldest · Popular
I had to have my sister send me money to get the Ventolin inhaler that I
need. I told my doctor off since he wouldn't do the appeal and said that I
could pay for it! I'm getting a new doctor! My doctor I had for 14yrs.
Would have done the appeal, but she stopped practicing to teach. So this
guy took over and he's lazy and horrible and doesn't do anything! I have
one refill left and will have to pay for it, unless the new doctor does the
prior authorazation and does it right.

On Apr 5, 2017 7:47 AM, "Asthma and Allergy Foundation of America" <
support@aafa.org> wrote:
Carrottop50 posted:

I can only use the Ventolin and the Ins. won't cover it now and gave me Pro Air and it doesn't work for me! Now I don't have an inhaler that works and I'm 66 with Asthma and Bronchitis and a heart condition. The Ins. doesn't care if you drop dead! My doctor did a prior authorization for the Ventolin and they denied because it's not on the formulary list anymore! My cousin said to contact the manufacturer. Does anyone know if that works? I can't afford over $56 for one inhaler since on Disability and social Security.

I'm severely allergic to peanuts and cannot use proair. Pro air is  manufacture it on the line that has peanut contamination.  Whereas ventilon isn't.  I am on social security and I cannot afford that price. However maybe it's the part D drug plan you have. If you were to change up you might be able to get it covered. Or your doctor should be getting samples .my doc provides me with samples .

Welcome, Carrottop50 ... I agree with Allison that the blog post What to Do If You Can't Afford Your Asthma Medicines can give you some other ideas. 

Also, does your pharmacist or doctor recommend that you use a spacer with the newly prescribed inhaler? If so, I would try it before you give up on the inhaler. Several of our members have talked about how spacers really help to get the medication down into your lungs.

I can only use the Ventolin and the Ins. won't cover it now and gave me Pro Air and it doesn't work for me! Now I don't have an inhaler that works and I'm 66 with Asthma and Bronchitis and a heart condition. The Ins. doesn't care if you drop dead! My doctor did a prior authorization for the Ventolin and they denied because it's not on the formulary list anymore! My cousin said to contact the manufacturer. Does anyone know if that works? I can't afford over $56 for one inhaler since on Disability and social Security.

drodgers1965 posted:
Heather1 posted:

Wow!!!! I have been fighting for three months to get my Proair inhaler back because of how Ventolin does NOT work!!! They just finally approved an override yesterday because I refused to use it anymore. At the doctors office two days ago and they made me use the Ventolin after I repeatedly said no. It didn't help and I was immediately back at the pharmacy trying to get my other inhaler back... I've gone over three months without a decent inhaler because of this. I am furious!! I have been saying for months that the Ventolin DID NOT WORK... 

I can't believe u prefer proair over ventolin!!!!!   I would die if it wasn't for my ventolin inhaler!!!!!    Proair does nothing for me!!!!!

The Proair doesn't work for me but works for my daughter. Everyone is different. Unfortunately the insurance companies will NOT approve the medicines that asthmatics need even though our life depends on them. Diabetics have the same problem. If the government wants to change anything, it's how asthmatics are treated by insurance companies!

Leona posted:

I have suffered with asthma for 40 years now.   I have used Ventolin for at least 35 years.   I am no longer able to get ventolin as I am told by the pharmacy it is on "back order"    I have tried proair and a generic ventolin called apotex.   NEITHER of these work for me.   At 50.00 a pop ( that is with insurance)  it is very expensive to try these new inhalers only to find they don't work as well as  Ventolin.   GSK..... Please bring back Ventolin !!!!!    This is not like it is an elective drug...... I NEED it to breathe 

thank you

Have you tried calling around to different pharmacies? Because of the recall it probably put the stock on back order. The same thing happened to my daughter's medication and I had to sit and call every pharmacy til I found one that happened to have some in stock. Good luck. 

I have suffered with asthma for 40 years now.   I have used Ventolin for at least 35 years.   I am no longer able to get ventolin as I am told by the pharmacy it is on "back order"    I have tried proair and a generic ventolin called apotex.   NEITHER of these work for me.   At 50.00 a pop ( that is with insurance)  it is very expensive to try these new inhalers only to find they don't work as well as  Ventolin.   GSK..... Please bring back Ventolin !!!!!    This is not like it is an elective drug...... I NEED it to breathe 

thank you

Heather1 posted:

Wow!!!! I have been fighting for three months to get my Proair inhaler back because of how Ventolin does NOT work!!! They just finally approved an override yesterday because I refused to use it anymore. At the doctors office two days ago and they made me use the Ventolin after I repeatedly said no. It didn't help and I was immediately back at the pharmacy trying to get my other inhaler back... I've gone over three months without a decent inhaler because of this. I am furious!! I have been saying for months that the Ventolin DID NOT WORK... 

I can't believe u prefer proair over ventolin!!!!!   I would die if it wasn't for my ventolin inhaler!!!!!    Proair does nothing for me!!!!!

We reached out to GlaxoSmithKline today and they have provided this information for us:

"In response to some of the questions raised on this forum, any person with concerns about this voluntary recall, or if you believe you have an inhaler from an affected lot, please contact the GSK Response Center for instructions. This call is free of charge.  The lot numbers affected by the recall are Lot 5ZP1708 and Lot 5ZP1951.

Please do not go directly to your pharmacy without calling the Response Center, as operators will have information on the voluntary recall and, if applicable, clear guidance for you on the return and free replacement process.  Pharmacists may also call in if they have questions.  The phone number is 1-888-825-5249, Monday-Friday, 8:30 am - 5:30 pm ET. There is no charge for this call."

I do apologize! I switched a number around. Thanks for getting back to me so quickly. I moved recently and my pharmacy is in another state. I will see what I can do to get another prescription sent to me. Thanks

This is a real recall put out by the FDA - but many pharmacies did not receive it. One option is to print out the FDA recall press release and take it to the pharmacy. They can call GSK as a medical representative.

I tried calling and didn't get anything about being charged for the call. What option did you choose?

I called the numbered for GlaxoSmithKline and they are charging .69 cents to $1.69 per minute for the call! Why would anybody need to pay a company to get information on this recall??

 

What's up with this nonsense and is this a real recall??

Kirsten - If patients have questions regarding a Ventolin HFA unit, or wish to know if their inhaler is included in the recall, they may contact GSK’s Customer Service Center at 1-888-825-5249, Monday-Friday, 8:30 am - 5:30 pm ET.

Heather - that is frustrating. I've heard other say that one works better than the other for them even though they are the same medication. And it's different for each person - not all saying that one brand works and the other does not.

Wow!!!! I have been fighting for three months to get my Proair inhaler back because of how Ventolin does NOT work!!! They just finally approved an override yesterday because I refused to use it anymore. At the doctors office two days ago and they made me use the Ventolin after I repeatedly said no. It didn't help and I was immediately back at the pharmacy trying to get my other inhaler back... I've gone over three months without a decent inhaler because of this. I am furious!! I have been saying for months that the Ventolin DID NOT WORK... 

UPDATE from GlaxoSmithKline: "Based on the questions you seem to be receiving, it’s important to point out that the voluntary retail-level recall affects only two lots of Ventolin HFA, in the US. The recall does not extend beyond the US. The lot numbers are 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 expiry date of December 2016. Lot 5ZP1951 was manufactured on 22 August 2015 with an expiry 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.

If patients have questions regarding a Ventolin HFA unit, or wish to know if their inhaler is included in the recall, they may contact GSK’s Customer Service Center at 1-888-825-5249, Monday-Friday, 8:30 am - 5:30 pm ET. If a patient believes his or her Ventolin HFA inhaler is not effective at relieving his or her symptoms, the patient should seek immediate medical attention from his or her healthcare provider."

Hi Laura,

We are contacting GlaxoSmithKline to get more information about this recall. In the meantime, call your pharmacy and/or doctor to ask them about getting a new inhaler. If they are unaware of the recall, let them know it was listed in the FDA Enforcement Report for the Week of December 16. It is a Class II recall that was initiated on December 3, 2015.

We will update our blog and Facebook page as soon as we have more information.

Thank you!

×
×
×
×