Second Fentanyl Patch Recall issued

Austin Kirk

By Austin Kirk
Posted February 19, 2008


Two fentanyl patch recalls have been issued over the past seven days due to a risk that users or handlers of the powerful painkiller could experience respiratory depression or fentanyl overdose after coming into contact with the patch. Two different manufacturing defects at different plants have resulted in recalls involving the brand name Duragesic pain patch and generic fentanyl patches sold by Sandoz and Actavis. The fentanyl gel in these patches could leak out and come into direct contact with the skin, resulting in serious and potentially fatal injuries.

>>PRIOR POST (2/13/2008): Duragesic Pain Patch Recall

On February 13, 2008, Johnson & Johnson issued a fentanyl patch recall for 95 lots of their 25 microgram-per-hour patches after a manufacturing defect was discovered. Some of the pain patchers were found to contain a slice along one side of the drug reservoir, which could cause the fentanyl gel to leak. That recall applied to brand name Duragesic pain patches and generic fentanyl patches sold by Sandoz, Inc., which were both manufactured by Alza Corporation, an affiliate of Johnson & Johnson.

Yesterday, a second fentanyl patch recall was issued for 14 lots of generic patches sold by Actavis, Inc., which include 25, 50, 75 and 100 microgram-per-hour patches with an expiration date between May 2009 and August 2009. These patches, which were manufactured for Actavis by Coruim International, could have a “fold-over” defect, which may allow the fentanyl gel to leak directly onto the skin.

The recalled Actavis fentanyl patches could also contain the former name of the company, Abrika Pharmaceuticals, on the pouches that contain the patch. The official list of products impact by this week’s fentanyl patch recall includes:

  • Actavis Fentanyl Transdermal System, 25 mcg/hr. NDC 67767-120-18
  • Actavis Fentanyl Transdermal System, 50 mcg/hr. NDC 67767-121-18
  • Actavis Fentanyl Transdermal System, 75 mcg/hr. NDC 67767-122-18
  • Actavis Fentanyl Transdermal System, 100 mcg/hr. NDC 67767-123-18

Both this week’s and last week’s fentanyl patch recall pose a serious health risk to users of the powerful painkiller. Direct exposure to fentanyl gel could lead to respiratory depression or a potentially fatal overdose. Users and caregivers who place the patches on their loved ones have been advised to thoroughly rinse any area of the skin which comes into contact with fentanyl gel with large amounts of water, but soap should not be used.


The lawyers at Saiontz & Kirk, P.A. are reviewing potential fentanyl patch lawsuits on behalf of individuals who suffered an overdose death or other serious injury as a result of the powerful pain patches. In addition to injuries caused by defective products, reports indicate that hundreds of fentanyl patch deaths could have been caused by the manufacturers’ failure to properly warn of the serious risk of overdose.

If you, a friend or family member have suffered a fentanyl overdose or death as a result of the pain patch, request a free claim evaluation.

20 Comments • Add Your Comments

  • Annette says:

    I have been on the Duragesic Patch for three years due to chronic pain syndrom in my L4, L5 which pushed against my S1 nerve root. As well, the pain in the hip and entire c Spine and L Spine areas are herniated and bulging. I have made a point to walk a lot everyday to loosen up the joints to brgin each day.

    Today I saw my neurologist for my monthly follow up. Uponf filling my Fentanyl with a generic named Mylan. THe patch is completely different. THere is no gel, it is just like the patched you see people wear for their hearts, etc.

    It is fast acting and it all but eleminates the actual sources of the pain, Plus, the new patch is about 1 X 1` inches and appears to be even better than the gel fillerd pacthed,

    Thank You and May God Blesss you eternally.

    Posted on April 4, 2008 at 2:01 am

  • Donna says:

    I am writing to alert people, just as “Annette” had in April 2008, that the generic pain patch “Mylan” is the safest pain patch to wear. I have been using it for over a year now. I does NOT have the gel in it and thus, you cannot overdose. It is flat and it stays on better too.

    I have searched to see if any recalls have been issued on this and I cannot find any. I believe it is because of this new technology.

    Why don’t the “powers that be” just change them? Forget the gel, this patch works!!!!!!

    I hope someone reads this and spreads the word. There are too many unnecessary deaths happening over such a simple solution!

    Posted on October 11, 2008 at 10:49 am

  • jeffrey says:

    I have been on mylan 100mcg for 3-4 mos., due to an injury, at night twice i felt as if i was crawling out of my skin, cramping, squirming, sweats, chills, shakes, crying it was so bad, almost went to hospital. My Dr., said it was a panic attack, never had this happen before being on this med. they said take a xanax before bed to help .Now this patch helps somewhat with the pain , but I never want to have a “panic attack” ever again with these recalls I am concerned of course, now what??

    Posted on November 23, 2008 at 5:43 pm

  • jeffery says:

    When the doctorfirst put me on 100 mcg patches, I ended up in the hospital with chest pains so severe I thought I was having a heart attack.I was already on anxiety medicine(klonipin).I just knew I was gonna die. About a week later I ended up with some Kind of psychosis and was E.O.D.ed to a mental hospital for two weeks with delusions and hallucinations…and Im still having some of these problems.What can I do? I dont wanna die.

    Posted on February 3, 2009 at 12:14 pm

  • Jim says:

    Jeffery Says # 4 and #5 posts. Your problems seem to be of a mental state.. Anyone that suffers from panaic attacks would probably have the same systems you have with this medicine and the news surrounding the recalls. I have been on Mylan for three years with absolutley no side effects. They stick better than any other that I have used. Your #4 post suggets withdrawal systems not overdose. When first taking these patches it sometimes takes up to seven hours for the full effect of relieve. Overdose would result in sever breathing difficulty in any opiate. The fact that you have these mental problems should have been discussed with your doctor beforehand. Nothing is impossible,but I seriously doubt the problems you state are related to the Mylan patch. If it were the brand name Duregesic, the I would worry. It is possible the Dr. prescribed too strong of an dose. Esepecially if this was the first use of this drug. I post this with respect to your problems and in no way was it meant in a demeaning manner.

    Posted on February 13, 2009 at 6:13 pm

  • Max says:

    Dude that is mylan fentanyl patch withdrawal symptoms believe I know
    it is terrible and the worst state of affairs when the dr puts you on the highest dosage of the strongest medicine known to man. that is abuse if I ever saw it then you are in worse pain far worse pain than when you began. It is horrible to think I never even took an opiate before the dr gave me a 100mcg patch and just try stopping taking them you can’t you die my heart stopped and the so called professionals w/ there bs you don’t die from withdrawals my ass. You can go into cardiac arrhythmia from simple cold medicine. And this drug is 100 times more potent than heroin I hate those damn arrogant nurses like you deserve it mentality I never knew this is what this fucking drug did. Now I am as good as dead and more are going through this my insurance was canceled I can’t afford this now and guess what I am going to die but I will be damned if I go through the pain and indignity of withdrawal again before I start to go into cardiac arrest.

    Posted on March 8, 2009 at 5:15 am

  • Keith says:

    I had been on 50mg of methadone for about 2 yrs now and am having no pain relief today my dr put me on the duragesic patch (generic) He said I could get brand if I wanted is anyone experienced enough to know witch one is better and stronger for pain? he told me I might have to go up to 75mcg patch but I want the one that works the best any ifo would be helpful, He also said i could try avizia and opana. I have scolosis and several herniated disc and disease of the bones and disc.

    Posted on March 24, 2009 at 10:25 pm

  • beanmachine says:

    I was on patch from Mylan for 2 years when the pharmacy switched to the wwatson gel pack patch . I have never been so irritated by a product in my life. It was awfull. It didn’t stay on and I constantly had ups and downs like I was on something I had never been on. Now I think the Watson patch was the prob. it must have been delivering the wrong dose the whole time. I fought with the pharmacy to get the Mylan patch back and they said I was not the only on complaining of problems more than just one I might add. I had massive side effects from Watsons GEL PACK PATCH!!! It took months to get back on the Mylan but when I did it was WORTH IT!!!! If you have to be on a med like this USE THE MYLAN BRAND. It sticks on better is flat not as irritating to mave with everthing.!!!!

    Posted on June 8, 2009 at 1:57 pm

  • Jane says:

    I have been on various pain patches continually over past 7 years. Durgesic had severe withdrawal symtoms on 3rd day, respiratory problems, etc. Been on Sadoz, etc but recently changed to Mylan and find it is smaller and stays on much better. I don’t break out and itch like I did continually with others. Some companies will provide at no cost cover patch for people who have a hard time keeping on. These are very expensive if purchased as developed for burn victims and when I found them after Durgesic quit supplying they were $19each!! Mylan does supply these on request or did when I last researched. In reading all this, I am alerted and wonder if last few months of pain and pressure in my chest could be from the patch? I am schedule for a nuclear stress test next week and dread that experience. I nearly died from Bacterial Endocarditis twice and anxious with any thing causing heart prolems. Good luck

    Posted on June 9, 2009 at 12:17 am

  • BECKY says:


    Posted on June 11, 2009 at 12:19 am

  • sharon says:

    i have been on the 50mg. patch for about two years.some thug or theif walked right into my home MY HOME!! and took it right of the counter,and me in the next room husband was i am really hurting.i am six from withdrawels.i ask to be took off of it 3 or 4 times,but he would not do it .now i am hurting BIG TIME!! i have allways took pills, i could control those.when he change my pills,it never never bothered me.i allways watched what i took you cant do it with the patch.i never want back on those try to get off and see what i mean.its in your system all the time.gods helping me threw this but i feel sorry for the guy that took them.god will punish him big time. god be with you all !!!!

    Posted on June 26, 2009 at 2:08 am

  • Margaret says:

    I have been on the fentanyl patch for about 5 years or so now. It keeps my pain mostly away, I do have breakthrough pain for which I have meds to take care of that. BUT, I also have panic attacks, had them before fentanyl and still do occasionally. I have 2 different kinds of panic attacks, one is a disassociative panic attack which is weird, the other is feeling like everything is closing in. A .25 xanax takes care of that.
    As for the person who was prescribed 100mcg of the fentanyl patch, that, in my humble opinion, is way too much to start with. I started with 50 and have been on 75 after a few months.
    The patches are expensive, J&J is about 600.00 for 30 days worth, and generic is almost 400.00 for a months worth. But, it is worth it. I have MS and the pain at times got so bad I couldn’t stand it. I tried different modalities, shots in the back, etc and, since the pain is all in my head (lesions on the nerves in the brain) they didn’t work. The pain doctor, and I had gone to many of them, said I needed a psychologist, meaning he thought it was all in my psychological head. I had already beat him to that. I gave him my psychiatrist’s name, because the pain was so bad I thought I was going crazy, thus the psych. I got my pain control and have been on it ever since. And I must say, I like the Mylan patches better.
    Also, I take offense at people saying we are addicts, addicts will kill to get their “high”, I do not get high, just relief. Yes, I am dependent on them for pain control, but not addicted.

    Posted on July 28, 2009 at 10:39 pm

  • Jeremie says:

    I was perscribed Mylan fentanyl patches about a year ago and have had problems since. My dr. started on 50mcg and went to 75mcgs. First, I’ve had blood pressure and heart problems since and severe hallucinations and anxiety with very aggressive tendencies. No matter how much I eat, I lost over 50 lbs. in 4 months and I just feel horrible. Also, I have constant muscle spasms in my neck 24 and 7 and I’ve acturally tried to get off of them 3 times and was successful twice with the help of hydrocodone. Never try to do it alone if possible. Its too dangerous!! but the whole thing of being in so much pain got me to get back on them. My Doctor refuses to put me on anything else no matter how much I plead the how much the side effects and drug is killing me. This is so irresponsible I cant even wrap my mind around it.

    Posted on August 5, 2009 at 1:01 pm

  • RNS says:

    My mom died July 27 2008 of a fentanyl overdose. Beware… and be cautious. She was 51 and should still be alive today.

    Posted on November 19, 2009 at 2:31 pm

  • oneluv says:

    Ive been on percocets for a year now due to a clavical injury from a car accident as well as sever nerve damage. I was just given a fentanyl 100 patch and im curious about the reactions my body will go through. If i dont like the way i feel on it can i stop using it after my first time? will i get withdrawls symptoms from using it only once? Will I be able to function once the patch kicks in? Could i take it off if i dont like the way i feel on it? and if i can how long will the medician stay in my system?? Sorry about all the questions…im just a little worried of the unknown…if anyone could help that would be awesome..thanks!!

    Posted on February 4, 2010 at 3:05 pm

  • Will says:


    First and fore most ask your doctor or pharmacist those same exact questions. Medical advice provided over the nternet should be considered suspect until it can be verified by a doctor.

    also remember this when readin some of these comments. Often times pepole blame every little issue they hve after first starting a medication with out finding out if it is even a side affect of the medication. Some have even had these issues prior to the medication, but bamed the medication any way. Every thing I have read indicates that Fentayl does no cause panic attacks or make you see things. there is a possiblity they are suffering from somthing eles at the same time.

    dependancy happens over time, so if you use one patch you are most likely not going to have withdrawl symptoms. But again talk to your doctor, He or She, is the best person to explain this.

    Posted on March 25, 2010 at 4:00 am

  • k hoover says:

    I’ve been on the Duragesic patch, then I think mylan, sandoz; all of these started out as a resovoir patch, but then changed to what they call a matrix patch which means there is no resovoir gel; the durg is in the glue and they did not stick very well and if they came off it was impossible to get them back on especially if they stuck to them selves; the resovoiir is the best for me; you can use tape or “Bioclusive”, now I am on Watson and they have changed the amount in the resovoir, because I change them every 48 hours and since Dec.’10 they only last 30-35 hours. Can anyone tell me a better generic that is in gel form (resovoir patchj)????

    Posted on April 7, 2011 at 12:24 am

  • robert says:

    I may have to come off my 100mcg. fentanyl patches for a period of time.This will be due to possible insurance coverage loss. I’m aware that this will require medical monitoring..what to do?? cannot manage the pain or withdrawal symptoms that come with this.Why is it,when you have legitimate health problems/pain/severe spinal damage..they attach such a stigma to it? just like the mental health field?

    Posted on September 24, 2011 at 1:02 pm

  • John says:

    There is another hazard with these patches. If you get in direct sun and patch is heated and you sweat, look out for an overdose. Especially seniors. This has happened to me. And by the time you realize what is happening, you are down and out. I am not in an air conditioned place 24-7. Its frustrating. If you try to get off them, the withdrawal is mind boggling. I am sorry the doctor ever put them on me.

    Posted on October 4, 2012 at 12:56 am

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