Dexamethasone Injection Recall Issued Due to Particulates

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By: Staff Writers | Published: December 27th, 2010

Contamination by particulate matter has led to a recall of seven lots of dexamethasone sodium phosphate, an anti-inflammatory medication distributed by American Regent, Inc.  

The dexamethasone recall was announced on December 20 by the FDA, after some lots were found to contain particles that formed before the expiration date. There have been no injuries or illnesses connected to the contaminated injections. 

The recall affects seven lots of dexamethasone sodium phosphate injections, USP 4 mg/ML, 30 mL Multiple Dose Vials with lot numbers 8811, 9093, 9195, 9296, 9419, 9505 and 9649. All of the recalled injections have expiration dates ranging from 12/2010 to 9/2011. 

The injections were distributed to wholesalers and retailers nationwide. While the company said that the recall was precautionary due to safety concerns in its press release, it did not state what the safety risks of dexamethasone injections contaminated with particles could be. It also did not specify the nature of the contaminating particles. 

Dexamethasone is a steroid that is used as an anti-inflammatory and immunosuppressant. It is often used to treat rheumatoid arthritis and often used as part of chemotherapy treatment in some forms of cancer. It is also used by mountain climbers to treat high altitude illnesses, like high altitude cerebral edema. It is sometimes used illegally by athletes for sports performance enhancement. 

American Regent says it is crediting accounts for all returned products in the affected lots. Anyone with questions should call the company’s customer service department at 1-800-645-1706.

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There Are 29 Comments So Far • (Add Your Comments)

  1. How can they say there is no illness or injuries????? I became very ill from the treatments I was having with dexamethasone. I was having very serious symptoms that were considered anaphylactic and I am not completely over them yet. I started the dexamethasone treatments at the beginning of December and I stopped them after my 7th treatment before I found out anything about a recall. I do have a recalled lot number on my bottle. I was having terrible effects and I just knew something was wrong with this drug. I am now waiting to find out more information on the long term effects from this mess up. Can anyone give me more information about this?? The company is just ignoring my request for infromation. I wonder why??? I have seen two doctors because of my reaction. I’ve had to take alot of benadryl to try and conteract the dexamethasone.
    It gave me horrible insomnia, choking, swelling in my throat, gums , neck and my head felt terrible. I could not function. My christmas and new years was ruined. My family is so worried about me because they can tell I’m not feeling right. Any help would be appreciated…..

  2. It has been almost 2 months since I had the treatments with Dexamethasone and I am still feeling horrible. I am seeing a specialist soon regarding the effects I am having from this drug. Right now I can’t function normally. I am swelling and am in terrible pain everyday. I can’t work and can hardly get through the day. I firmly believe it is from these treatments. It all started after about 6 treatments but I had 7 total treatments. I put a stop to them before I knew anything about the recall. Like I said I have a recalled bottle. I wish the company would come forward with more information about the adverse effects this drug is causing. I’m VERY SICK from this drug and am looking for HELP. My Doctors are taking this very seriously that’s why I am now going to a specialist. I just want to feel good and normal again. I am quite afraid of what has happened to me.

  3. I was taking this drug also. I had a brown vial of it at home. I have secondary adrenal insufficiency, very similar like Addison’s disease. I was in an acute adrenal crisis last May and injected several times 100mg. I noticed the bottle had floating particles in it and questioned administering to myself at that time, but had no choice in the matter because I was in a life or death situation. I went out of state for a meeting and lost my vial which was replaced with solu-cortef, but I know for sure now that vial I had of dex was a recall. My lymph nodes have been swollen for sometime and have not gone down. They’ve had me on anti-biotics and now are furthering blood work. I did not know there was a recall on this drug……no one told me and I have had been injecting with it. If you do other searches you’ll see the drug was causing things like lymphomas, Crohn’s, lung fungus, and a few others. Well, I want to be tested for all those things to make sure I don’t have those.

  4. Part of my physical therapy was dexamethasone mixed with a gel and applied with ultra sound on my ankle. Any danger there?

  5. I have just found out about this (apparently second March 17) recall of this drug. I have had multiple injections but through a a padded system (not direct injection through the skin).

    Can others who are experiencing problems which vehicle was your injection. What type of specialist are you seeing so that I may consult the appropriate doctor immediately.

    thank you

  6. The specialist I recently saw is an immunologist. He tested me for everything and determined that my symtoms are from the Dexamethasone. I am still swelling in my neck and it is very painful. The doctor has me on antihistamines but they don’t seem to be working very well. I want to know what the company plans on doing about this. I have been suffering since December. I had the ionopharisis treatments. That is when they inject into a pad and electrically administer the Dexamethasone into your body. Mine was injected this way into my shoulder several times until I knew something was very wrong and stopped the treatments. Then I found out I have a recalled bottle. I am looking for others to come forward so we can get together and talk about a possible law suit against this reckless company. I can’t even go for job interviews because I’m in pain and can hardly sleep because of this swelling. I am searching for an experienced lawyer that specializes in these kinds of cases. Is anyone else out there with me on this? I am in fear of the long term effects of this adverse reaction I am still having since December. I have no idea if this is going to go away and how long it will take to subside. Any assistance would be appreicated.

  7. I am so sorry for everyone’s difficulties. I came upon this site as my doctors are recommending dexamethasone iv to treat my chronic daily fever and other systemic symptoms associated with Rosai-Dorfman disease. Thank you for sharing your stories as I have now solidified my decision that I will refuse this treatment. Best wishes to you all and thank you.

  8. This is definitely scary. Is there a forum or blog for people adversely affected by Dex? We need to talk. I had severe swelling of the tongue (something I never had in my life); still having terrible sleeplessness, pain t/o body, arthritis conditions in hands, feet, neck, etc. I want to know what are some common diagnoses for Dex recall affects and what is the treatment.

  9. I had three vials of dexamethasone inyected in February,2011. My drug store just sent me a letter telling me they could have had “particulates”in them.
    What am I supposed to do?
    Thanks,
    Caridad

  10. Dear Nicki, I can’t find a forum or blog for this but we need to do something about this. I’m Lori and have written a few times now. I to have terrible sleeplessness and pain and swelling in my right hand and horrible swelling and pain in my right shoulder and neck from the treatments I received with dexamethasone. I contacted the company and they won’t even give me and information . I’m going to a specialist again next week and going to give him the names of the people I contacted at the company that makes this drug and ask him to contact them for some help. He has come to the conclusion that my problems are all stemed from the Dexamethasone. I am unable to get a job or function with out terrible pain everyday. I need answers and find out how to conteract this drug. It has now been 5 months since this started and I’m really nervous about how long this is going to to on and what the effects are long term. The company is trying to brush it off but I am not going to let that happen if there is anything I can do about it. Are you with me on this? I am seeing an Immunologist and he already did a full work up on me with the conclusion that my problems are comming from the Dexamethasone. I will continue to update my progress.

  11. I was injected with this product for a root canal. My face swelled and I had a water bubble under my eye. People thought I had Bells-palsey or a stroke. I went to the ER and they were puzzled. I was sent to an Oral surgeon, and a neuroligist. I had a CT scan. No one could help me. Finally the symptoms left after a week. I was slurring my words, but it would come and go. My tongue felt like it was swollen and then it went away, but would return again.

  12. It is now August and I still have the same horrible swelling on the back of my neck and shoulder from dexamethasone. My doctors don’t know what to give me to stop it. I never had this serious problem until I had the treatments last November! No one has helped me. I KNOW THAT THIS IS FROM THESE TREATMENTS. I WISH I COULD GO BACK TO BEFORE I HAD THE TREATMENTS AND JUST PUT UP WITH A LITTLE SHOULDER PAIN I WAS HAVING WHEN I DECIDED TO TRY THIS TREATMENT. I AM LIVING WITH SWELLING AND EXTREME PAIN EVERYDAY!! DOES ANYONY HAVE ANY SUGGESTIONS OR WHERE TO GO FOR HELP. I CAN’T WORK OR DO MUCH OF ANYTHING. I TRIED WATER THERAPY AND EVERY OTHER KIND OF THERAPY BUT NOTHING HAS WORKED. LIKE I SAID I WAS NOT LIKE THIS UNTIL AFTER THOSE STUPID TREATMENTS AND THEN I FOUND OUT MY BOTTLE WAS RECALLED ON TOP OF IT ALL. HELP

  13. It is October 5, 2011 and I am still having horrible side effects from the Dexamethasone treatments I received last Nov. – Dec. 2010. My neck and trapezeal muscles are so swollen I can hardly function. They had gone down a very small amount for a short period of time but now my neck and trap. muscles are so swollen and the pain is so horrible I can’t sleep or do any normal day to day tasks. I also still get a choking sensation off and on. I am now having extreme physical therapy but it is not helping very much. I don’t have any diagnosis other than it all started when I received the Dexamethason treatments with the recalled bottle. I need to find out if there is a law suit pending regarding this medication. I am very scared and have been in so much pain since last December. I know it is from these treatments.

  14. I am writing again because I am still suffering from the effects of a recalled bottle of dexamethasone that was used for my treatments on my shoulder. I received iontopheresis treatments last December 2010. Please if any of you out there have suffered or are still suffering (as I am) I urge you to call the FDA. You can find their phone number on line. You should fill out a formal complaint against the company and the drug dexamethasone and state your injuries stemming from the treatments you have had especially if you had a tainted bottle as I did. I spoke to the FDA yesterday trying to get more information as to what to do about what has happened to me. I’m still suffering and my doctors now know it is from the Dexamethasone treatments. I need help in finding out what to do to remedy my adverse side effects. I have seen every specialist and tried all kinds of medications and therapy with no relief. I can’t function normally, I am in pain 24/7 and have extreme swelling that goes up and down a very little bit only to flair back up again constantly but never leaves my body. It effects my nerves, my brain and my muscles. I still have insomnia from this drug which is horrible in itself. I URGE ANYONY ELSE THAT HAS BEEN ADVERSELY EFFECTED FROM THIS DRUG LIKE I HAVE TO COME FORWARD AND REPORT IT TO THE FDA IMMEDIATELY. THERE IS STRENGTH IN NUMBERS. I KNOW THERE ARE MORE PEOPLE OUT THERE SUFFERING LIKE ME.

  15. Are there any attorneys out there that will help me with a lawsuit against this company. I have all the medical documentation needed to pursue a lawsuit. I am still not well at all after having treatments with a recalled bottle of Dexamethasone. I had no idea I had a tained bottle until after I stopped the treatments on my own because of the horrible adverse effects this drug has caused me. I am swollen all the time and have terrible sleeplessness. The pain is unbelieveable. I can’t functrion normally day to day. At my neuroologists office I am being treated by a myofascial pain management person. He told me to get on the internet and look for a lawsuit against this company. They know this all started when I had treatments for a right shoulder with a little bursitis. This drug has destroyed my life. I’m trying everything to counteract this drug but nothing has worked.

  16. Just updating my condition. I am now going to be referred to Doctors in Boston, MA. I have been injured by the drug Dexamethasone and the doctors in my area do not know how to help me. I am exhausted of all the tests and therapy I have been through. Ever since I had these treatments with Dexamethasone my condition is unchanged. I’m suffering every minute of every day. I have to put lidocaine patches on my neck to get a small amount of very temporary pain relief. The swelling does not go away and the pain is horrible. The sleeplessness is unbareable. I have notified the FDA of my injury from my RECALLED BOTTLE OF DEXAMETHASONE. I had already notified the company and they don’t seem intrested in helping me. Their only concern was getting my bottle back. I did not send my bottle back. An attorney I recently spoke with told me that I was very smart in not returning that bottle to American Regent. I am waiting to find lawsuits against these companies because I will be filing my own soon. First I will take the trip to Boston in hopes of finding a remedy to what has happened to me. I’m sick and I’m scared. I was not like this until I had those treatments. I wonder why this site will not let me put my email address so others can contact me regarding their injuries from this drug. I tried to post it but they won’t allow it. So please write to me on this forum. I can’t believe American Regent first said that there are no injuries from this recalled drug. B— S— I am injured from the treatments with DEXAMETHASONE…………

  17. i also received contaminated dexamethason,after four tx. for a long thoracic nerve injury through ionophoresis, i developed incresed pain and swollen lymph nodes that are located in multiple areas of my body.
    THIS HAS BEEN GOING ON FOR 9 MONTHS. I HAD TO HAVE SURGERY AND HAVE A VERY LARGE LYMPH NODE REMOVED FROM MY RIGHT GROIN IN AUGUST OF THIS YEAR, I HAD NEVER HAD ANY OTHER PROBLEMS LIKE THIS BEFORE IN MY LIFE PRIOR TO BEING EXSPOSED TO THIS PRODUCT, I TOO HAVE WENT TO MULTIPLE DOCTORS WITH, NO CONCLUSION YET, i ALSO HAVE CONTACTED THE FDA, SURELY THERE WILL BE A LAWSUIT ON
    THIS EVIL PRODUCT SOON.

  18. Dear Holly, Thank you for sharing your experience with DEXAMETHASONE. I am going to see a Neuro/Muscular Specialist on January 26th. I have been suffering for a year now. I had the ionophoresis treatments last November/December 2010 and have been suffering ever since. My pain increased I am still very swollen in my neck and muscles. I have already seen several specialists. The only relief I get is by placing lidocaine patches on my neck and top of my shoulders for a few nights in a row. It’s like giving myself novacaine on a regular basis. It’s CRAZY. I get headaches from the patches but it’s the only thing that gives me SLIGHT TEMPORARY relief from the horrible pain I feel. It does not take down the swelling though. I also have horrible insomnia from this drug. I’m so gald you notified the FDA. More people must come forward and report their injuries from this drug now. I am constantly looking for a law suit against the companies responsible. Even the pain management specialist I was seeing told me to get on the internet and look for information regarding this drug and a law suit against it. He can clearly see that something terrible has happened to me from the treatments I received and no one has been able to help me. Please keep in touch through this site and let me know if you find any more information. I will do the same. I was hoping it would just leave my system but it has been 12 months and I still feel horrible and am swollen. It’s a NIGHTMARE………. My family is so upset and are praying all the time. They know I was not like this before these treatments. I just had a women email me from another site and told me her husband was injuried from treatments with Dexamethasone. Their story is similar. Was your bottle recalled? The bottle that was used in my treatments was. I did not know I had a recalled bottle and stopped my treatments myself because I started felling horrible after 7 treatments and haven’t felt right since. A week later I got the letter telling me my bottle was recalled and to stop any treatments but it was to late. I want to get well first and foremost and I also want the companies involved to PAY…..
    Regards, Lori

  19. LORI, thankyou for writing back about this medication nightmare, my vial was also contanimated,on 01/10/12. I went for another ultrasound of my groin and my r underarm, I still have mutiple swollen lympnodes with some very large, the pain is insane, I am so sorry for what you have been through. and I appreciate your concern I will pray for all those
    affected….I am going to another, Dr. this week. to rule any other problems. I know in my heart of hearts, that this medication caused all
    of our problems,i wan’t them to pay and I truly feel like we have a case. We need to keep communicating until we find one.
    Take care, Holly

  20. Dear Holly, I’m so glad that you are keeping in touch. I too just went to another Neuroligist/muscular MD. He asked me if I had spoken to the pharmacutical company about the recalled Dexamethasone. I told him they will not talk to me or give me any help. He understood why. This is rediculious. All these symptoms started after my 7th treatment with DEXAMETHASONE. I clearly have all my medical records in order. I was treated with a recalled bottle. This Doctor is going to take an MRI of my neck. I am praying that someone of importance will finally put together a lawsuit against this company. I have been suffering and I mean suffering for a litle over a year now. All I can do is novacaine myself to get temporary relief. It’s just not right. I do hope other people effected by this drug will PLEASE come forward before it’s to late. I strongly believe we have a case against them. I can’t work and am lucky to have one good day out of a week. No Doctor can find any other reason for my pain and symptoms. It narrows down to the treatments I had with this horrble drug. Please keep in touch……………..

  21. Lori, again i am so sorry for your agony,i had to go through a pet scan
    due to my swollen lymph nodes and terrible pain,worried for a week that i had cancer, thank god no cancer,but i still have no clear answer to this crazy mess, lymph nodes aare still swollen and painful, in march it will be a year also after this reaction after four treatments, please keep in touch , i know this caused all our problems. would love to
    make someone responsible for, we know that this is what is ……….

  22. Hello…has anyone had any luck finding an attorney for this? I have been in contact with 3 and all told me they couldn’t help. I received my injections in my ankle and about a month later had swelling and inflammation that eventually turned into large draining wounds that were the most painful thing I have ever experienced. I went for several months of wound care and in March of 2011 I had surgery to remove a granuloma formation from the wounds in my ankle. The drug company keeps replying that I had an infection caused by the dr office where I got my injection, however, all the bloodwork and cultures tell a different story…I never had an infection….I too, had a reaction the the particulate matter…and I had all of the results listed on the recall notice…in order…right down to the granuloma formation! I am so frustrated…this has resulted in lose of motion in my right ankle, I drive cars for a living, so it has affected my ability to do my job, a year after surgery, I still have pain…and I have a pile of medical bills about 2 feet tall…I am told that I have about 15 days left to start a suit before my statue of limitations runs out. Any advise???

  23. Has anyone received payment from Glako Smith Kline. My attorney keep saying they never received payment but on facebook payment was made in Feb.

  24. I’m still enduring swollen lymp nodes and pain from this medication,has anyone found a lawyer who will help us out.

  25. i was called by luitpold pharmaceuticals last year that my vials were recalled. i had suffered symptoms prior to the phone call. i now have lesion in both my ankles and require surgery. my tendons are also torn. Surgeon suggest the cause could be the steroid inections i was on for treating my Pituitary tumors with Adrenal INSUFFICIENCY. I NEED REPRESENTATION. I KNOW I HAVE A CASE. THIS ISNT FAIR TO SUFFER DUE TO THEIR NEGLIGENCE. I AM UNABLE TO WITHSTAND STANDING ON MY FEET FOR OVER A YEAR NOW. ACTUALLY IT BEGAN A YEAR AND HALF. DURING THE PERIOD I WAS ON THE INJECTIONS. I WAS CONTACTED AGAIN BY THE COMPANY TO SIGN A RELEASE AND I WOULDNT.

  26. Does anyone have avascular necrosis of the hipfrom decadron. I am suffering from this and will need a hip replacement. Does anyone know of a lawyer?

  27. I was given the dexamethasone injection on June 27, 2012 and immediately I started to get a negative reaction. Specifically my face with numb. I lost my sense of taste and smell. That numbness has now taken complete control over my body. My muscles are weak. I have the following test to rule out that it maybe something else: MRI, CAT Scan, Nerve Conductive Test and a MRI of the Brain. All of the test show normal. It was not until after I had the injection that I’m feeling this way. I’m still having numbness, no energy, lifeless, no taste or feeling.

  28. I was given this medication Dexamethasone in March 2011 after three treatment I had a Stroke. This medication was suspose to help my Elbow with an injury, but instead I cannot cope with anything.i am in pain, lost my balance, memory loss, vision, cannot enjoy Life like I used to. I am also angry, fatigue, speech problem, moody, don’t enjoy sex,. What can we do?

  29. I happen to run across this site while looking for something against the use of dexamethasone (tablet form)…my husband took this medication that was prescribed to him by the VA….then within a short time, he was dead. I too have been trying to find an attorney who would handle a case against the company who makes this drug. If ii is Glako-Smith Kline, they know there are in a lot of trouble and hiding evidence as much as possible through their attorney’s. I am going to continue to look for a attorney. If anyone else finds one, let me know.

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