Bristol-Myers Begins Avalide Recall

by pharmacy on September 30, 2010

Bristol-Myers Squibb has announced a recall of its blood pressure medication Avalide. The recall covers 60 million tablets that were manufactured before 2009 in Puerto Rico and distributed in the United States and Puerto Rico.

The recall is a precaution after it was discovered that there might be variations in one form of the active ingredient in the tablets. The variance would cause the tablets to dissolve at a slower rate than usual. The company released a statement that they do not have any evidence that the medication has reduced potency, but have initiated the recall because they are unable to rule out that possibility. Predictability of medications is a necessity for physicians and patient evaluations, and it is possible that any variations in the drug might impact the course of treatment.

Since other lots of the drug were not impacted, the company does not anticipate any shortage of the drug to stem from the recall.

http://www.msnbc.msn.com/id/39420100/ns/health/

{ 102 comments… read them below or add one }

Jo Steinhauer January 7, 2011 at 6:03 am

How do you know if your medication Avalide is effected? My husband has been taking this for years now. He has been having side effects recently. What do we do to find out about his Avalide??

Jennifer January 11, 2011 at 12:32 pm

@Jo: take the bottle to your pharmacist and have them the lot number for you. I hope all is well.

Deborah Bell January 12, 2011 at 10:53 am

The statement about there not being a shortage is false. I and my pharmacy have searched for days and there is none available. Also it is very difficult to trace which lot your previous avalide is from due to the pharmacy is reluctant to release that info. Also I have had an unexplained increase in blood pressure over the past 3 weeks. I am conferring with my physician about a new b.p. med. Avilide too risky!

JANET January 12, 2011 at 8:40 pm

I USED TO USE AVAPRO AND MY INSURANCE PLACED IT IN A HIGHER TIER AND I HAD TO CHANGE. I NOW HAVE A NEW INSURANCE AND WAS PUT ON AVALIDE (WHICH IS SUPPOSED TO BE AVAPRO WITH A DIURETIC). IT WAS CALLED INTO A SAMS CLUB TO BE FILLED AND THEY INFORMED ME OF THE RECALL.
SAMS CALLED THE SUPPLIER AND THEY DIDNT KNOW WHEN THEY WOULD GET MORE IN. COME ON BRISTOL -MYERS THERE ARE PEOPLE WAITING FOR THIS DRUG. I HAVE REALLY WAITED ABOUT 3YRS AS I HAD TO CHANGE BECAUSE OF THE TIER PRICING. WHAT ARE WE DOING MANUFACTURING OUR DRUGS FROM PUERTO RICO ANYWAY?

Jackie Polson January 13, 2011 at 6:33 pm

When I ask Caremark for an Avalide refill recently, I was told they were out of stock and did not know when they might get it. I was not told there had been a recall. Instead, a Caremark pharmacist told me the company was probably having shipping problems.

A pharmacist at Walmart told me there had been a recall of Avalide.

I would like to be treated like an adult by Caremark. I would like to know if my current Avalide was made in Puerto Rico and if it is part of the recall. I cannot get honest answers.

Noel Montalvo January 14, 2011 at 7:03 am

This has nothing to do with the drug been made in Puerto Rico. There are the same high standards than in the rest of the nation. Most of the most highly cualified drugs are made here without any problems so I recent the implication that this has something to do with my island. Errors happens anywhere in the world and it has to do with an ingredient that comes from the US and remember that Bristol is an american company.

Panzie M January 14, 2011 at 2:50 pm

I have a full bottle of Avalide tha i am currently takinng, should I discontinue taking this medication?

Mozelle Friday January 14, 2011 at 6:51 pm

I have been on avalide150/12,5 for quite some time. I had a very scary and weird feeling, rapid heart beat 166 elevated b/p,nervous .I was admitted to the hospital treated remained for3 days. dec 30th 2010 to jan 2nd

willis cason January 14, 2011 at 7:39 pm

i feel like this january 2011 and this kind of thing should not be going on i been feeling weird lately myself i was told that there was a recall but dont worry we have plenty well if there was a recall why would want to keep taking the dam things im scared

denise cameron January 14, 2011 at 7:51 pm

I WANTS TO KNOW WHY THE DOCTOR DID NOT INFORM ME OF THE RECALL, HE PRESCRIBED IT TO ME ON LAST MONTH., IF THEY ARE NOT SURE ABOUT THE EFFECTIVENESS OF THE DRUG,THEY SHOULD OF TOLD THE DOCTORS TO INFORM THEIR PATIENTS THAT WERE TAKING THE MEDICATION, WE WERE PAYING FOR SOMETHING THAT COULD HAVE HARMED US., WHAT I WANT TO KNOW IS ALL AVALIDE EFFECTED IN THIS RECALL OR JUST SOME OF THEM. I BEEN TAKING IT FOR ABOUT 4 YRS NOW. AND I AM REALLY WORRIED NOW ABOUT WERE IT DOING ME ANY GOOD,

Racheal January 15, 2011 at 3:31 pm

I’ve had the same problems, Mozella. I ended up at the E.R. due to high BP and rapid heart beat too. I’ve since went to the doctor because I can’t seem to get better. I was taking Avalide 300/12.5 and yesterday my doctor put me on 300/25. I dropped my prescription off at Wal-mart pharmacy early Fri morning 1-14-11. After already checking on my script twice, a pharmacy employee told me that they were out of Avalide & had a shipment coming in Mon. I asked why I wasn’t notified & does another pharmacy have any in stock. He told me to call around & ask. Turns out another Wal-mart pharmacy had 64 tablets in stock. I then had to call the original pharmacy back to have them fax the script. I THEN was told that the drug had been recalled. Of course the pharmacy would not give me any reasons why the drug had been recalled. This whole situation frustrates me and we should have been notified.

Ivan January 16, 2011 at 8:26 pm

My last prescription of Avalide was filled on Oct 4/10. I understand that the order to recall this medication occurred on Sept 20/11 so I wonder why my prescription was filled. I’m on 300/12.5mg which is the format that was recalled. Apparently it didn’t affect the 150/12.5mg format.
To-day I went to Costco(Canada) to renew my prescription as I was unaware of the recall until I was told by the pharmacist who said that the manufacturer still had not released a new format.
It is interesting looking at various side effects that I may unknowingly have experienced some of these due to the pills. Maybe it’s time to change medication.

Debra Meyer January 17, 2011 at 8:37 am

I was informed by pharmacy that Avalide was recalled. I was shocked my Doctor didn’t know and why the Medical Reps. didn’t inform my Doctor.
I was out of BP medication , now switched to Benicar HCT. I was taking Avalide for years, now switching to new. BMS not right for all taking Avalide!!!! Shame on you!!!

BEAR January 17, 2011 at 3:16 pm

WENT TODAY TO GET REFILLS,HAVE NOT HAD A PROBLEM AT ALL,MY DOCTOR EVEN GAVE ME SOME SAMPLES BECAUSE I WAS GETTING LOW. WHAT THE HECK IS GOING ON? WHAT WERE SOME OF THE SIDE EFFECTS. I HAVE BEEN FEELING FUNKY LATELY BUT JUST THOUGHT IT WAS THE ANTIBIOTIC I HAD BEEN TAKING

Paula January 17, 2011 at 3:42 pm

The avalide recall lot numbers can be found on the FDA.gov website under Enforcement Reports for November 10,2010

Elna January 17, 2011 at 3:57 pm

I have taken Avalide for a number of years. I was not told about the Recall. I just saw my Doctor this week and she reordered Avalide. Aetna did not tell me there was a recall. They told me there was a backorder and they did not know when the drug will be available. This is wrong. I notes that with this barch of RX that I was getting headaches but I worry because my Doctor stated that my B/P was acceptible. WOW

Diane January 18, 2011 at 10:10 am

My husband has been on Avalide for years now and has just recently been told that Avalide is on recall. Our co=pay is a percentage so now that he has to take double the amount of pills because the 12.5 strength is still available, Bristol-Myers does not want to offer any coupons for the difference. They just stated that Avalide is on back order and they have no idea when it will be available. Their is no patient assistance program available forthis product since it is on Backorder! Way to go Bristol Myers!

kayo January 18, 2011 at 10:54 am

Why cant our drugs be MADE IN AMERICA. Look at all the recalls with things made in China. It’s about time we came home.

Bobbi Wawrzenski January 18, 2011 at 5:30 pm

Have been wating for my refill of Avalide from PRESCRIPTION SOLUTIONS for weeks and only received letters stating they are out of stock and awaiting arrival from other distributors. FINALLY, today I spoke with my local Sav-On Pharmacy and was informed Avalide was recalled. Filed a complaint with Presciption Solutions for not informing their patients of the recall. Come on now, this is messing with people’s lives. Now waiting for a callback from my physician to inform me what she is changing me to. THANKS PHARMACEUTICAL INDUSTRY, ESPECIALLY BRISTOL FOR ALL THE CUSTOMER CARE!!!!!!

Carol January 18, 2011 at 7:26 pm

I, too, wanted to renew my perscription for Avalide. I was told by my mail order pharmacy (Medco) that it wasn’t available and that it was back ordered. Never was the word recall mentioned. My prior perscription to Avalide was filled on 10/6/10. I feel that Medco had plenty of time to notify me that this medication was being recalled. I’ve been having headaches and my blood pressure has been running high. Perhaps a class action law suit is in order.

Robert January 18, 2011 at 8:15 pm

I too have been taking Avalide for years for my blood pressure.
Today, 01/18/2011, I went to my pharmacy CVS to get a refill only
to be told that the medication had been recalled and my refill cannot be processed. I now have to wait for my Doctor to decide
which rx he will give me now. I am sad because until now this is the
only medication that has really kept me steady. I have to say though that the last week or so I have been getting headaches,
nervousness, dropping and spilling things, and have had periodic
palpatations. I am surprised that not only did my pharmacy not call me but my Doctor did not either. Maybe that is because he
doesn’t know about it yet either. He will once he gets my message
tomorrow. Like one viewer noted maybe a class action suit is in
order for us Avalide users. Let me know if one happens.

Bob from NJ.

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Beverly January 18, 2011 at 9:39 pm

I also went to my pharmacy (walmart) this afternoon to refill my Avalide prescription and was told that it is on recall. ( I got scared …like WOW ….no ot Avalide) Unfortunately the pharmacy assistant told me the pharmacy did not know nor did they have any answer for the recall at this time. I have been taking Avalide since my baby was 4 yrs old, she will be 12 in July 2011. My side effects are not many, but the most serious is the frequent urination after I take the pill. My doctor recommended that I take the pill at night. This causes me however, to visit the rest rooms 3 to 4 times during the night which is disturbing. The other is cramping in my left arm which sometimes gets a little scary I must admit. I usually take a low dose aspirin just in case of a heart attack ironically- God forbid). Another is occasional shortness of breath after climbing the stairs as I am very active and only a few pounds overweight. I will difinately have to see my doctor tomorrow even though my pharmacy promised to call him on my behalf. The Avalide unfortunately is the only HB pressusre med that has given me the better result thus far in term of balancing my systolic/diastolic blood pressure reading in spite of. I hope Bristol/Myers will soon get the problem resolve one way or another….I do pray that neither of us will have any serious/permanent side effects as a result of the deviation in the ingredients..I will be keeping in touch with the reports……..May God bless us all….

Rose January 19, 2011 at 3:51 pm

I tried to refill my avalide prescription with medco and was only told that it was not available through them and that I should refill it at my local pharmacy. I contacted the review and appeals office of Medco to see if they would allow the copay rate at the pharmacy since it was not availavle through them. They looked into why this medication was not available and told me that it had been recalled. I would like to know why I was not notified about this and only told that it was not available. I will do more investigating into this and want some answers not only from medco, bristol meyers and my local pharmacy since I renewd it there recently.

David Tyrrell January 20, 2011 at 3:16 pm

For those who are unaware, Puerto Rico IS the United States.

gordon palka January 20, 2011 at 9:00 pm

I FOUND OUT YESTERDAY THAT I CANT ANY MORE AVALIDE. TODAY WE PHONE TO RENEW MY PRESCPTION AND THEY SAID THAT I CANT GET ANYMORE. WE TALK TO MY DOCTOR YESTERDAY AND SHE NEVER HEARD OF THIS. IN THE FEW MONTHS I HAD A HEART ATTACK, AND HAD MANY OTHER PROBLEMS, SUCH AS MY PLUSE WAS VERY LOW IT WENT DOWN 30, AND I WENT TO HOSIPAL. AND THEN A COUPLE WEEKS LATER MY PLUSE UP TO 120. AGAIN I ENDED UP IN HOSIPAL. IF THERE IS A PROBLEM WITH THIS PILL THEY SHOULD HAVE LET US KNOW ..I DO BELIVE THAT A CLASS ACTION SUIT SHOULD BE STARTED TO SMARTED UP THEM I HOPE..

Wanda January 20, 2011 at 9:00 pm

For Kayo, Just so you can be better informed , Puerto Rico officially the Commonwealth of Puerto Rico “Estado Libre Asociado de Puerto Rico”, literally Associated Free State of Puerto Rico, is an unincorporated territory of the United States, located in the northeastern Caribbean Sea, east of the Dominican Republic and west of the Virgin Islands.
So yes Those pills were made in the United States.
Also it’s not the first time that medication has been recalled . This has happen many times in other pharmaceutical that are on the main land .

Chuck January 21, 2011 at 2:49 pm

Ditto the above problems and symptoms. Caremark/CVS told me there was a recall only after I called and ASKED THEM about it. And as of today, there is none available. Both the partial and full bottle I have are on recall. They would fax my Dr. for an alternative. They will send a mailer to let me return my Avalide for credit. According to Caremark, they do not notify customers of such recalls… only the physicians. And I heard nothing about this from my GP physician even though on Jan 4, I saw him for a checkup and he renewed the Avalide Rx. My BP and pulse started doing screwy things only in the last two weeks since then. After then seeing my cardiologist and an EKG, the cardiologist suggested checking with Caremark. Bingo… crappy drug and crappy business processes by Caremark to deal with it.

Celia Fleishhacker January 21, 2011 at 6:51 pm

I cannot believe that so many others experienced what I had experienced when I went to get my Avalide perscription refilled. l) we are out of it. It will be in monday. Finally after much bluster I was told it had been recalled. No my Doctor did not know about it @ they would not refil the lower dosege. My perscription plan would not pay for an substitute. Cannot believe that the pharmacy, doctors and the patients were not informed. And Again the company is the Giant Bristol Myerss. Ha. Celia

Alice January 22, 2011 at 3:17 pm

I went to the doctor on Thursday January 20 for a refill of my medication Avalide, I have been on the drug for many years and he automatically renewed my prescription. A few days before I went I was not feeling very well, I had rapid heart beat and felt nausas afterwards, could this have something to do with Avalide? When I went to the pharmacy to get Avalide, they gave me 7 pills out of 100 and said they should be in the next day. I went back today January 22nd, and was told of the recall. I asked the pharmacist why they did not tell me when they gave me the 7 pill and said they did not know of the recall. Reading all your comments I know this is not true as the dates do not match up. By the way this was Shoppers Drug Mart in Cambridge, Ontario.

Fiona January 23, 2011 at 12:51 am

My MD called me to let me know about the recall. He called in two prescriptions to replace the Avalide which is a combination of Avapro (300mg) and hydrochlorothiazide (HCTZ) (12.5 mg). Simple.
Apparentlt, the only problem w/avalide is that it might dissolve slower therby taking longer to work on lowering the BP. I was afraid there would really bad side effects.
Bristol Meyers should compensate patients on the extra money I have to pay for the additional medication,

Leonardo January 23, 2011 at 9:51 am

I read all the comments from here an other websites as well. I think that the easiest solution for everybody is to buy avapro alone with the diuretic in substitution of the avalide. That should be as effective as the avalide. Talk to your doctor about it.

Mike January 24, 2011 at 1:34 am

I was not informed of the recall by my pharmacy or by my physician. I just had a six month check-up with him on Friday. Not only did he not mention the recall, his nurse called in a refill of it on Friday. Only discovered the recall when I went to pick it up today. The pharmacist informed me that they no longer had the drug and neither did any pharmacy in our area. I have been having a rash and itchy all over for months now and after reading all this, have found that you are not to take Avalide if you are allergic to Gantrisin. Interesting that neither the physician or pharmacist put the two of them together……both have my allergy lists Also have the fluctuations in BP and weakness/breathlessness. Just who can you trust?

Geoff Curtis January 24, 2011 at 7:08 am

The clerk at Shopper’s Drug Mart explained that they had run out of my usual, 2 ingredient, blood pressure pills (Avalide) and they were giving me separate pills that added up to the same dosage, if I take both pills. No problem, I’ve taken them that way before. Later, when I opened the package, I discovered that they’d charged the dispensing fee twice. I thought, that’s a good racket, run out of something and end up getting twice the payment, so I phoned up to complain.

The woman on the phone explained that the fees had been charged twice because it wasn’t their fault that they had run out. The manufacturer had recalled the Avalide pills and none were available. Whenever a substitution is made, they have to contact the doctor, for approval, and duplicate the paperwork. I suggested that this would work well for the pharmacy’s bottom line and sarcastically commented that I should be thankful that there weren’t 5 ingredients in my medication, so that they could charge 5 times the amount. When I asked her what was wrong with the original pills, she passed me over to the pharmacist on duty.

That was a waste of time! The pharmacist had to be told that there had been a recall. She then proceeded to give me a song and dance about how the drug company might have wanted to change their packaging. For instance she said, “Maybe they wanted to convert something like a 20 pill blisterpack to an 18 pill blisterpack.” She backed off when I suggested that recalls were serious business and the manufacturer would not likely recall product, just to change packaging. She clearly wasn’t interested in further discussion and offered me the name and number of the manufacturer (Bristol Myers Squib), if I wanted to find out more.

Not content to wait for the next business day, I did some internet research of my own and discovered that Health Canada had posted a recall on Oct. 11, 2010 and FDA of the US had posted a recall on Nov. 10, 2010, of numerous lots of Avalide, that had been distributed worldwide, because they were classed as a “Type II” (moderate) health hazard. Mistakes had been made in their production, causing variations in the solubility of the main ingredient (Irbesartan), which could lean to patients receiving incorrect dosage. I was also able to print out a list of the affected lot numbers.

Given, that my previous prescription had been filled on Nov. 19, 2010, after the recalls took place, I called back to ascertain the lot number of my remaining Avalide pills, so that I could determine if there were any efficacy or safety concerns. The same pharmacist answered my call but said that there was no way to determine the lot number of the pills dispensed on Nov. 19, 2010 , as all the pills had been sent back to the manufacturer and there would be no record of their lot numbers. I confided in her that I had previously worked in the pharmaceutical distribution industry and knew that a detailed paper trail had to exist, as this was essential to any recall. She claimed to have no knowledge of this and that she would leave a note for her manager, the owner of this Shopper’s Drug Mart, Debby Costa, so that she could call me back.

As the next business day, Friday, Jan. 21/2011, is now almost over, I phoned back again and got a different pharmacist, who knew of my request for a call-back, but didn’t know herself, how to get me the lot number I requested. When asked, she admitted that the manager would not be in today, and didn’t know for sure when I would hear from her. “Okay” she said, to which I replied that it was not okay, as I still had a supply of questionable drugs. It was me, not her, that suggested that it might be a good idea to discontinue using the leftover pills.

I am appalled to learn that the professional pharmacists, who are dispensing my prescription drugs, do not know how to proceed with a drug recall, and one of them wasn’t even aware that there was a huge recall of widely used drug. Not exactly a confidence builder for Shopper’s Drug Mart, or the drug distribution system!

Marge January 24, 2011 at 2:12 pm

I went to the Dr today to have prescriptions renewed. He renewed my Avalide. I took it to Pharmacist and he said he didn’t have any but would get it today and deliver to me. This afternoon he phoned saying it had been recalled so he would get in touch with Dr to see what I should take. He did phone back and is replacing it with 2 other meds…one is a diuretic.
Why didn’t the Doctors know about this?I had Avalide renewed in Nov.

Janice January 24, 2011 at 7:36 pm

I called my pharmacy for a refill of my Avalide today (1/24/11). The pharmacist came on the line as the Walgreen’s automated system told me there was a problem with my prescription request. When the pharmacist came on the line, she informed me that “certain lots” of Avalide had been pulled by the FDA. She told me the rest was on back order. I asked her what the concern was with the medication and she said, “I don’t know. The supplier and the company have not sent out an explanation. Call your doctor and ask what he wants to do.” I called dr. Doctor thought it had only be a specific lot that had been recalled. Now I’m awaiting a decision about what medicine(s) I’ll be switched to. I think we need a better notification system. I just went to dr. in December and got the refills approved!

Wanda January 25, 2011 at 11:53 am

From a few pages that I’ve have read it seems that Bristol-Myers is offering all eligible current AVALIDE patients the option of receiving AVAPRO and hydrochlorothiazide (HCT) at a reduced co-pay for both pills .
Not sure how true this is but may have to ask your doctors about this .

Wanda January 25, 2011 at 8:55 pm

I have been taking Avalide since I had a heart attack several years ago. Now I just found out about this “AVALIDE 300-12.5″ recall and “shortage” problem. I went to Wal-mart to get my refill. First I was told there was a recall. Then they told me that the manufacturer was delaying shipment. They wanted me to accept a three-month supply each of Avapro for $160.00 and HCT for $7.34. HUMMMMM, isn’t that a total of $167.34??? I was paying $50.00 for three-month supply of Avalide. IN ADDITION, I was told I had a stroke on my optic nerve January 13, 2011. This was probably caused from my BP dropping TOO low during the night. I have already made an appointment with my cardiologist. NOW I will also discuss a change in BP meds. DOES ANYONE KNOW WHAT IS GOING ON???????

Ted January 26, 2011 at 2:36 pm

I went to Wal-Mart today and I was told that Avalide was on recall. I asked the Pharmacy and he could not tell me. He first told me that it was out of inventory. I don’t get it as it sounded like they were trying to hide something. The Pharmacist said that he would call my Dr. and I said not to. I said this because, my doctor did not advise me that my medication was recalled. Another time I received a letter from my insurance company and the Hyzaar (BP medication) that I was taking had been taken off of my insurances company’s formulary. My doctor did not know this as well and I had to tell her. I had a year’s worth of prescriptions so when my doctor gave me the prescription in February 2010 for avalide, she did not know of the recall. You would think that all doctor’s offices would get a notification and wouldn’t you think that they would do a check? Wouldn’t you think that the Pharmacy, Wal-Mart, would know of this? I told Wal-Mart not to call my doctor’s office as I try to figure out what is going on. Please help.

Mary Ann January 27, 2011 at 9:49 pm

I have been on avalide 150-12.5 for several years. This medication has worked quite well for me, but recently I have had a problem with my heart beating fast from time to time. I don’t know if this had anything to do with the medication. I called my doctor’s office last week to have them call my pharmacy to get a refill. The doctor’s office was not aware of the recall. I was informed by my pharmacy and now my doctor has prescribed diovan and I’m not too happy with it. It makes me feel funny and I’ve been getting a headache every time I take it. I would like to know when avalide will be available again because I want to switch back to it as long as it is safe.

Sandy Joffrion January 28, 2011 at 12:21 pm

I have been on Avalide 300/25mg for about 4 years with no problems. My BP has been great. I tried to refill my Rx on 12/31/10 at WalMart & was told this drug was on back order. My insurance company’s pharmacy, CVS, informed me that this drug was no longer in their preferred list, meaning a higher copay but they said nothing about a drug recall. I informed my doctor about the Avalide 300/25mg situation and gave her the list of comparable drugs per CVS information. My doctor and Walmart were not aware of this recall and had not been informed by Bristol Myers of this change. My doctor prescribed Micardis, one of the Rx listed on the list from CVS. I took this Rx for 5 days and my BP went sky high. So, my doctor prescribed Avapro with HCTZ hoping this will correct my BP problems. I think Bristol Myers should have advised the pharmacies and doctors about this problem prior to the situation. I do not remember advertising of any kind regarding Avalide in the newspapers, tv or radio regarding the problem. I think the decision to continue taking Avalide 300/25 should be left to the consumer and doctor after learning all the facts.

NJCathie January 28, 2011 at 4:57 pm

Geoff Curtis (and all Medco customers):

Geoff, I use a distributor called Medco and I am pushing as hard as you, not only with the distributor for not notifying me of the original Recall in September, but for calling this a “shortage” and not a Class II recall. I’m keeping a running total of all conversations not only with Medco, but the FDA (who is still calling it a shortage), Bristol-Meyers (BMS) and my husband’s Benefits department at his work.

BTW, BMS said they sent a letter out to all Doctor’s and Pharmacuticals the week of January 4th stating that this was a “Recall” and Medco informed me today they received notification on January 7th that it was a “Recall”. My belief here is when they called me on the 18th to tell me of the “shortage” they lied, because headquarters knew it was a recall, they didn’t pass it on and didn’t want to create a panic – so one Medco rep told me.

My doctor has been having a problem balancing Avalide with me for months and has even added Toprol on top of it. Had I known of the September recall I would have taken matters into my own hands and changed Avalide.

I am demanding a change in Medco’s policy and throwing down the gauntlet on this one. I should have been notified of the September recall, giving ME the right to address it with my Doctor AND determining that it was Avalide that was the problem that was forcing me to take additional medications to balance my BP.

I officially put in a complaint directly with Medco – they were notified on January 7th of this Class II recall, but on the 18th they called me to say there was a shortage….and that is just wrong. I have put an additional complaint in with BMS and the FDA. The FDA confirmed the recall on January 18th and said they would adjust their website (because everyone references it), but as of today….there has been no change to the FDA website elephant that is suppose to be protecting US.

This is my life and if I am forced to use a mail in pharmacy for 90 of pills, then they darn sure better tell me if there is a “RECALL” vs. “Shortage”. Medco sent me an original BMS bottle that shows the Lot and Expiration date…and yes, it’s part of the batch of 65 million pills – and yes, I took 90 day worth of an unstable medicine. This medication has been unstable since before September. Truth be told, If you really look through the history of Avalide, I think I saw their was an issue in 2009 also.

Everyone on this site needs to start filing complaints with the CORPORATE offices of their pharmacies and demand the complaint numbers and follow up procedures. Same with the Bristol-Meyers Squib Consumer Response Team and the FDA. If you are this concerned, then do as Geoff and I am doing and push for your rights or they will just brush you off – it is after all, your life and you can’t possibly believe THEY care unless you make THEM care.

Document every conversation, date, name of the person you talk to and what they say – you’ll be surprised how little everyone knows. Ask for a complaint number or reference number (Medco calls them CRTS #’s to be responded in 72 hrs, then they change them into Grievance #’s, to be responded to within 20 days – but has been responding very quickly). Ask how quickly you should expect a response.

Things in the healthcare industry has been changing so fast our minds are spinning, but if we don’t speak up LOUD and CLEAR, it’s going to pass us by and we will be at the mercy of nameless, faceless, empty corporate offices and ignorant frontline customer service pharmacists.

Don James January 29, 2011 at 4:57 pm

I went to walmart today and have 2 days left, screw the company that makes this stuff, everyone should have been informed of this by their doctors and the company that makes so that they can switch to avapro with 12.5 mg dia and the problem would have been solved, But no they have to be misinformed and lye to all of us , I hope they are sued over this mess,

Connie January 29, 2011 at 9:35 pm

I just want to say that someone should have told us that there was a problem with our medication. I have felt as if something was wrong but I thought it might have been the stress of the holidays. I have been having palpitation and a feeling light headed. Has anyone else been having this problem?

Steve January 30, 2011 at 7:17 am

Here Is A Copy From Nov 10, 2010 Of THe Recall From the FDA Website

RECALLS AND FIELD CORRECTIONS: DRUGS – CLASS II

___________________________________

PRODUCT

Avalide Tablets, (irbesartan/hydrochlorothiazide), 300/25 mg, 2, 7 and 14 count blister packs and 30 and 90 count bottles. Also labeled as 1) Coaprovel; also 2) Karvezide and 3) Avapro HCT. Recall # D-030-2011

CODE

90 count: 8J36036A , 8J36040A, 8J36041A, 8J36044A, 8J36046A, 8J36047A, 8K35927A, 8K35925A, 8K35935A, 8K35950A, 8K35954A, 8K35955A, 8K35957A, 8K35960A, 8K35963A, 8M27617A, 8M27619A, 8M29523A, 8M29528A, 9A55780A, 9A55781A, 9A55782A, 9A55789A, 9C48867A, 9E53024A, 9E53027A, 9E53029A, 9E53030A, 9F49882B, 9F49886A, 9F49889A, 9F49890A, 9F49893A, 9J47021A, 9J47023A, and 9J47027A — 30 count: 8J36039A, 8J36042A, 8J36043A, 8J36045A, 8K35928A, 8K35930A, 8K35931A, 8K35932A, 8K35936A, 8K35951A, 8K35952A, 8K35956A, 8K35961A, 8K35964A, 8M27615A, 8M27616A, 8M29524A, 8M29526A, 8M29527A, 9A55786A, 9A55787A, 9E53023A, 9E53025A, 9E53026A, 9E53031A, 9E53032A, 9F49883A, 9F49884A, 9F49892A, 9J47024A, 9J47025A, 9J47029A, and 9J47030A —- 2 Blister x14: 8K5936 2, 9A55790 3, 9F49888 5, and 9A55790 1 —- 1 Blister x 7: 8K35953A, 8M27618A, 9E53028A, 9F49887A, and 9A55793A — 1 Blister x 14: 8K35936 3, 9A55790 2, 9F49888 2, and 9F49888 4 —- 1 Blister x 2: 9F49888 3, and 9F49888 1 —- Coaprovel distributed in Mexico and Argentina: Blisters (2 BLP x 14) E018K35936, E028K35936, E038K35936, E048K35936, E058K35936, E068K35936, 8K35936 1, F359A55790, 9A55790 4, F839F49888, K599F49888, K609J47023, 9J47025 1 — Blisters (1 BLP x 14) C658K35936, F349A55790, F339A55790, F829F49888 — and Blisters (1 BLP X 2) 9A55790 5 —- Karvezide Distributed in Australia: 30 count: 921721, 923531, 922011, 925041, 925911, 924411, 928451, and 928421 —- Avapro HCT distributed in Australia: 30 count: 922131, 923371, 923551, 923521, 925341, 926941, and 928471

RECALLING FIRM/MANUFACTURER

Bristol Myers Squibb Manufacturing Co., Humacao, PR, by letter on September 10, 2010. Firm initiated recall is ongoing.

REASON

GMP Deviation: During manufacturing, the granulation time for the finished drug product was extended, which resulted in varying levels of Polymorph Form B. Polymorph Form A is the intended form. Polymorphism is the existence of different kinds/forms of crystal of the same chemical compound. In this case the extended granulation time changed Polymorph Form A to varying levels of Polymorphic Form B.

VOLUME OF PRODUCT IN COMMERCE

2,222,828

DISTRIBUTION

Nationwide, Canada, Mexico, Argentina and Australia

Rodney January 31, 2011 at 3:38 pm

Wow…lets sue!! If you are able to find this page you should be able to find Avalide.com and read about why it is being recalled like I did. I also called Bristol Myers customer line which was answered very quickly and am getting a valu-card which sets the max for the substitute, Avapro, at $20. Avapro is the same drug as Avalide minus the diuretic which must be prescribed separtely but is also covered with the card.

scot February 1, 2011 at 9:18 pm

is there any way to find out what lot number you have without going to the pharmacy?

Terry U. February 1, 2011 at 11:37 pm

I live in Canada. Developed hypertension about 2 yrs. ago. First put on Avapro and a diuretic. I am very sensitive to drugs. On this combo I had awful side effects. I was then put on Avalide. Been on it for 2 yrs. To me, a fantastic drug. No side effects; has kept my blood pressure at a fantastic level. Now with this RECALL pharmacy is giving me the Avapro and the diurectic. Again, sick from side effects. Must see doctor as to what else I can use — worrying, cause I’m so suspectible to side effects. Come on Bristol Myers — fix up Avalide and get it back on the market.

M Benkendorf February 2, 2011 at 10:12 am

My pharmacist suggested I get a prescription for 125-12 mg of Avalide. Take it 2X a day, or 2 pills at once. Whatever your Dr. suggests. I have made an appointment to see my own Dr. for this same solution.

haydee salemi February 2, 2011 at 10:41 am

i am so upset over this recall. this was the only medication that was working for me without any side effects at all. No swelling in my ankles, nothing… Please do something so i could go back to Avalide. thank you kindly. (407) 695-0984

Don February 2, 2011 at 12:47 pm

What is the “REAL ” reason for the recall?

I’m being told now that the company has stopped all production
of the Drug.

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