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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.

 

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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."

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Comments (41)

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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

L
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!!!!!

D

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.

C

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... 

H
Kathy P posted:

@Carrottop50 That's really frustrating. I've run into issues where the insurance still denied coverage on a med even after the doc submitted the proper documentation. I'm currently fighting to get a nose spray covered. The one I want (had samples) works better than the others I've tried.

 

I want Beconase or Qnasl for my nose.  I used Beconase CFC on and off from about 1975-2005 and it was always miracle.  They discontinued it!  Now they exclude it. It's a new trend I was reading that started about a year ago.

You have to appeal for medical necessity, anyone done this successfully for INS (inhaled nasal steroids?)  There is a lot of research saying untreated allergic rhinitis increases chance of hospital visit for asthma significantly.

G

@Carrottop50 That's really frustrating. I've run into issues where the insurance still denied coverage on a med even after the doc submitted the proper documentation. I'm currently fighting to get a nose spray covered. The one I want (had samples) works better than the others I've tried.

Have you contacted the insurance company to ask if there is further documentation they need? What is the appeals process? Is there a patient advocate you can speak with?

Has the doc considered trying the nebulized version of albuterol? Or maybe you've already tried it. The nebulizer machine is generally covered and the medication vials are usually inexpensive. It's not as quick or portable as an inhaler, but may be another option to explore.

Kathy P

I got a new doctor and he did the prior authorization correctly and It was still denied. They want to know why I can't use it.I left a message for my doctor to do the appeal and tell them it doesn't work for me.I'm still using the inhaler that my sister sent me the money for. I still have to use my inhaler in hot weather here in Az. It's 115 and tomorrow 117 and we've had dangerously hot weather. We already broke the record of 120 from 23 yrs.ago. I stayed in for 2 weeks because dangerous for my heart condition and hard to breathe. I had to go out this last Mon.and had to use my inhaler. We've had strong winds and bad ozone also. Unfortunately, the washer and dryer are outside in a shed and have to go out there tomorrow so since 117, will be alot hotter in the shed. I'm praying that I will be ok. Thanks for contacting me and asking.I appreciate it! I'm also praying that the Ins. Covers the Ventolin inhaler!

C
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:
C
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 .

J

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.

K8sMom2002
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!

D
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. 

D

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."

AAFA Community Services

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.

Kathy P

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."

AAFA Community Services
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