Thursday, January 7, 2010

Kirkman Labs Recall - January 2010

I saw a notice about this last night and I wanted to pass it along as I have not seen very many places online yet.  I did talk to Kirkman Lab's consumer service department who confirmed the problem.  If you use any of the Kirkman Labs supplements listed below, you may want to stop using the product and contact either Kirkman Labs or the store where you purchased the product for more information.

From what I understand, the following products could have problems -
  1. Zinc Liquid
  2. Super Nu-Thera w/o A and D 
  3. DMAE 50 mg. Chewable
  4. Super Nu-Thera Powder Orange
  5. B Complex Powder Pro Support
  6. TMG w/Folinic and B-12 Powder
  7. Chewable Vitamin C Tablets
The following is a copy of the notice (it would be nice if Kirkman Labs posted a notice on their web site, hint, hint) -

Dec 30, 2009

Dear Kirkman Distributor,

It has come to Kirkman's attention that a raw material supplier has been supplying Kirkman with substandard quality material that is higher in antimony content than what would be considered acceptable to the special needs community. Raw material supplier are actually not required to test for antimony levels routinely, so this problem did not come to our attention until a physician using Kirkman products brought the issue to our attention. We immediately had our laboratory research the issue which they quickly isolated and linked it to a specific raw material.

We have stopped using this material and have located and purchased a quality replacement which we will begin using immediately.



UPDATE : Kirkman has posted a notice about the recall on their website.

34 comments:

  1. I find it appalling that Kirkman would go ahead and use these raw materials, knowing that they haven't been tested for safety. It shouldn't be up to the end user to discover problems of this nature!

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  2. Did Kirkman ever find out what type of Antimony was in the zinc? The last comment on their site said they were working with the FDA to figure that out, but there was nothing after that, and that last post was Feb 3, i think.
    I just now found out about this issue, and have been giving my daughter the bad lot of zinc for months. No wonder the tummy aches, no wonder the vomiting, no wonder, no wonder, no wonder. And most, no wonder she started to run away from me every night when I came at her with the bottle of zinc. My husband is out of his mind angry, but we really don't know who to be angry with.
    Now that I know about the issue, at least I won't be giving her the tainted lot anymore, but what kind of long terms affects could this have?
    If anyone has more information, please, please share.

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  3. I don't think that Kirkman's has released any other information. I do know that all of the zinc that has been on the market since the end of January is free of contamination so if you purchased the supplements after that point you should be fine.

    For what it is worth, unless you were giving your daughter a huge amount of zinc, it is likely that there wouldn't be any harmful side effects from the antimony. My daughters were also receiving zinc from tainted lots and they did not seem to suffer side effects. And, more importantly, their blood work that was done afterward did not show any problems either.

    I talked to my children's MD back in January and, while he was concerned about the exposure (and the lapse in quality controls), he did not seem to think there was any major health risk.

    To the best of my (limited) knowledge, the antimony shouldn't cause stomach problems or vomiting. But it is possible for the zinc itself to cause problems like that. You may want to talk to your child's doctor and see if they feel you should do anything for your specific case.

    Hope this helps.

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  4. Thanks MJ, I appreciate your message. The zinc I had been giving her since last fall had been one of the tainted lots. I did re-order in February, and have confirmed with them that this newer bottle is fine. The amount of the tainted stuff I had been giving her was about 2 teaspoons each night. I still have some left in that bottle, and my husband insists that we keep it, in case there ends up being any serious issues. I am comforted by your words though -- and I really do appreciate it. Odd though, that Kirkman has not updated their comments as to the type of Antimony, because really, that would be most telling in terms of what kind of effects it could have on our kids. My own DAN! Doctor was concerned about this point as well. Now why he didn't inform me back in january about the issue, I don't know, and again, my husband is determined to find out why.
    We did heavy metal testing in late November (becuase we had just started DMSA) and she showed extremely high levels of Antimony then. Again, why my doctor didn't phone me, I don't know. And I didn't phone him either, thinking first, that I would be making an appointment with him soon and would discuss then, and second that we just started the DMSA, and maybe this is a good thing -- her dumping so much Antimony, which I was thinking, could have come from many different soursces. My daughter is Chinese, and spent her first year in an orphanage, with god knows what kind of conditions. One thing led to another and I didn't end up making the appointment with the DAN! until just recently, and that's when I found out. And even then, I really didn't grasp the whole thing when I was there in his office, which is why I didn't press the issue of why he didn't inform me.
    We are repeating heavy metal testing now -- blood,urine and stool with Doctors Data, and another blood through our local hospital. With repeats again of all these in one months time.
    I'm actually going to see the Kirkman people this weekend. I'm attending a conference here in Troy Michigan (American medical Autism Board), and if it seems appropriatae, i will ask them if there is any update.
    Last, I do understand that the zinc alone could be giving her tummy aches, or any of the other myriad of things I have her on... But it always seemed to be the worst for her just before bed (and just after I would give her the zinc). And unlike anything else that I give her (and I give her alot during the course of the day), she really did run away from me, saying it was yucky. (This from the girl who laps up cod liver oil, and gobbles up her Enhansa laced peanut butter!)
    I will be sure to post if I find out anything from the Kirkman people... many thanks!

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  5. That's about the same amount that my twins get, although we divide it up and give half in the morning and the other half in the evening. As we added a variety of supplements, we had to switch around when we were giving things to try and balance out what we were giving and to try to minimize the problems. For example, giving methylcobalamin in the evening made the twins hyper and gave them problems sleeping. It took us a while but we seem to have a pretty good balance going.

    I had to laugh at your description of taking cod liver oil. That stuff doesn't taste very good yet the kids take that and worse without any problem. Makes you wonder how well their sense of taste is working.

    Regarding Kirkman, I think this problem was a shock to them and I believe (although this is second hand) that they were quite upset that this happened. The recall did get off to a slow start but within a week or two they did get the word out decently well. We received an e-mail and a letter in the mail directly from Kirkman about the problem, although I think that is because we have bought supplements directly from their website and were on their mailing lists. If I were you, I would ask your doctor next time you see them why they didn't notify you about the recall. If they knew and didn't notify their patients that wouldn't be good.

    Regardless, it sounds like you are taking the right steps in dealing with the contamination and hopefully your daughter will be able to get all of the antimony out of her system without any problems.

    Hope everything turns out well.

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  6. I agree with "Raw by default"
    The FDA advised me that Kirkman knows they are responsible for their finished product.
    Type of antimony? It really doesn't matter to sensitive patients. Toxic means "toxic"
    My toxicologist advised that there is little known about individuals with special needs ingesting antimony for a significant amount of time (months) THE HEALTHY POPULATION can usually excrete antimony, however, the autism population is a totally different scenario.
    My son has had a huge regression and we have stopped using the product in late February (over a month after the recall, which hardly anyone knew about) While I was doing chelation, I was giving the zinc each night.
    DMSA can be used in chelating antimony as per my DAN doctor. The longest cycle and more milligrams was prescribed to assist in removing this "toxic heavy metal."
    Interestingly, he says my son wasn't harmed and could just stop using the product and the antimony would just come out naturally.
    Note: I bought the zinc at his office and wasn't informed of the recall. I had to learn it from another parent who's son also was having health issues and was taking the recalled Liquid Zinc.
    I don't care who the manufacturer is, Eli Lily or Kirkman.
    Thimerosol or vitamin. Shame on you for putting our children through this nightmare because you wanted to save a buck!!!! I am so pissed because, just like the vaccines, my son has suffered AGAIN from me TRUSTING the wrong people. I have been told before, but didn't want to hear any negativity. With the exception of a small few, this is all about money more than helping our children.
    I have been a Kirkman customer for years. I just got wind of the lead incident in their multi vitamins.(My son had off the chart lead levels and I could never figure out where the lead was coming from, his levels did just recently go down)
    I was advised by Santa Clara's district attorney's office that their name was taken off the supplement manufacturer list because they fixed the problem. How long was this going on before someone threatened to sue?

    Note: I was told by another parent in one of my several support groups, that they are one of a few who linked the antimony to the Kirkman products after having Doctor's Data test their child's supplements. (JUST FYI)

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  7. Hey sickandtired, I'm right there with you - sick and tired. We also bought the zinc directly from our DAN!'s office, but weren't informed about the recall until the end of March. Almost 8 months of taking it! And I think my DAN! is one of the doctors who discovered it. I'm not only pissed at Kirkman, but I'm pissed at my DAN!'s office for not informing me.
    Right after finding out (end of March) we tested stool and urine through Dr's Data, and the anitmony showed very elevated. We tested again about 6 weeks later, and levels were back to normal.
    That is a relief, but not knowing what long term effects it could have, it is frightening.
    After finding out (end of March), I stopped giving my daughter any zinc at all, but found her to regress into some pretty awful behaviors. But not wanting to give her any type of Kirkman product, and also not wanting to give her a liquid zinc (which she associated with yucky feeling), I just recently got some zinc picolinate and having been giving it to her with breakfast. It seems to have relieved some of her bad behaviors.
    But I agree, Kirkman will not get any more of my business ever -- and we were using quite a number of Kirkman products. My husband is hopping mad as well, and looking for someone to sue! Maybe we should get a bunch of us together for a class action??

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  8. Yes, I am not sue crazy, but just as we are seeing from the oil spill in the Gulf of Mexico, no one will ever change their carelessness unless they have to pay $$$. Our children are victims. Who else will fight for them? The DAN doctors? Not for free.....
    Sorry folks, but I have earned the right to speak after being in this situation for over ten years. Unlike today, I could not find much support. I trust my DAN doctor and yes, chelation has helped, but these companies are being careless. Does an innocent child have to die?
    Spread the word!!!!!! Only way anyone would represent us if necessary.
    Also, there are so many support groups out there now. We as parents have to be careful. So, don't ever let a support group try to pursuade you into questioning your own instincts. Not just Kirkman, anyone could take advantage of our despiration for the healing of autism.
    Note: Kirkman Labs was raided by the FDA just a few years ago for the promise of healing autism with one of their supplements. (check the FDA website)

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  9. Sorry about any mistakes in grammar or misspelled words.
    I have a child who is stimming pretty bad. I have to get off this computer, I am sure you on this site can relate! (desperation)lol

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  10. Is there a legal contact? for this. I am still sick at heart and so angry.

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  11. I am meeting w/ atty tomorrow. I suggest hiring one. This could be a class. SPREAD THE WORD on every web site as possible. Don't get discouraged as Kirkman employees may be posting as parents trying to smooth us over. Remember, no autistic child is the same as another. Unfortunately,I have seen it all.

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  12. First of all, let me just say that I can understand exactly where all of you are coming from. I had three children who were taking contaminated products for who knows how long and I was less than amused that when I found out about the problems. I completely understand the problems that something like this can cause and how incredibly frustrating it can be to learn after the fact that something you thought was helping your child was actually doing some harm. I am right there with you.

    And at the same time, I don't think that Kirkman deserves any special ire over this. The company may have been a little slower than they should have in getting the word out, but once it got going they didn't do too bad of a job. And in reality, almost every consumer company has had to recall their products at one point or another because of quality or contamination issues. Unfortunately, contamination is going to happen even with the most stringent of quality assurance controls in place. The real test of a company is in how it responds to problems and how well it prevents them from happening again in the future.

    Should Kirkman have been more proactive in checking for contamination? Maybe. There are a huge amount of substances out there to test for, and it is simply not possible to test for all of them. Even if you picked only the common ones, all of this extra testing is not going to come for free. Are you going to be willing to pay a significant premium on each supplement for the peace of mind of knowing that some extra testing was done?

    But the larger question, to my mind, is what were the motivations involved. Do you think that Kirkman purposely, intentionally, or maliciously set out to skimp on testing just to save a few bucks? I see no evidence that this is the case. My impression was that the company was as shocked by this incident as we were and has taken steps to prevent it from happening again in the future. Kirkman has (historically) been known for producing high quality products and had built up a lot of goodwill from the autism community and I don't think they would have knowingly endangered that.

    Maybe that is why this incident is all the more upsetting, because you had trusted Kirkman to produce good products only to find out that that wasn't always the case. Time will tell if Kirkman can repair the damage done from this incident. If you really are that upset with Kirkman, I would suggest that you vote with your wallets and take your business elsewhere.

    Regardless, while you are more than welcome to comment (or vent) here about anything relating the Kirkman recall (or on any of the other posts on the site), I am going to have to ask you from refrain from trying to organize lawsuits in the comments here, this is not the place for that.

    Thank you.
    MJ

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  13. Thank you MJ. Sorry, not my intention of trying to use site for legal purposes. Like any blog, just want to raise awareness as I still know of parents not knowing about the recall. Yes, I am sick and tired of seeing my son so irritable and frustrated. It breaks my heart. It's not so much about Kirkman's intentions. It is about our children suffering injury from a product that was not properly tested.Of course I use other products. However, as per my conversations with the FDA and Santa Clara County, "Under the Dietary Supplement Health and Education Act of 1994 (DSHEA) the the dietary MANUFACTURER is responsible for ensuring that a dietary supplement is safe BEFORE it is marketed."
    Increase in the price of their product is appalling.
    Either way, thank you for being "open minded."

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  14. Forgot to mention. Larry at Kirkman says that they will only pay for testing. I haven't received any type of reimbursement. Oops, my mistake. I did receive another bottle of liquid zinc in the mail. (lol)

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  15. RIDICULOUS! Kirkman is serving a population that cannot methylate toxins like the rest of us. THEY HAD THE RESPONSIBILITY to disclose to their customers that they were getting ingredients from China. They are reprehensible and negligent. This disgusts me. DO not excuse greed so easily at the expense of our very special children. My son was poisoned by this disgusting company. How could they possibly test for all the contaminents that could be in there? they couldn't; but they knew they were getting the stevia from a country with a history of toxic shortcuts (ref all the children that died ALL over the world-- from the toothpaste made in china) THEY had the responsibility of informing their special needs clients that they were/are getting ingredients from China. I will never EVER use this company again and I hope everybody sues them.

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  16. Amen! Can you believe they took the "Antimony Update" completely off of their Important Info section of web site?

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  17. I am concerning this issue for a longtime. I have the same emotion with you because my 2 years-old baby also took zinc liquid of Kirkman Labs. The harmful metal will last a long term and underlying, so I worried my baby's health very much.
    I consult some medical and metal datum. Any forms of antimony compound, like similar arsenic compound, is harmful to humanbeing. Different type of antimony compound has different toxicity.The most virulence is SbH3, chlorid and fluorid of antimony. In Kirkman Labs recall notice, Kirkman and FDA are identifying the type of antimony compound in infectant products. Half pasted till now, they have not inform which type of antimony compound!
    The medical and metal datum show that taking antimony compound, people will be drooly, bellyache, lax, vomitive, headache, inappetence, dyschizia, etc. My child has such conditions when takes infectant Kirkman Labs products. Until stopped, he became better. But he is drooly and cough frequently.
    The amassment of heavy metal may cause serious harmful result. So I want to find a institute to test my baby to know the accumulated dose of antimony compound. This is very important.
    After the body check, if the accumulated dose exceeds the acceptable dosedose or normal standards, we have to requre Kirkman compensate for it. But if the test result is good, we can forgive Kirkman Labs's faults.
    The following 2 question need be thought:
    1.Some data shows that after taking harmful Antimony, it will disapear in the blood, but will amass in liver, spleen and skin. There is a test problem. How to test the accumulated dose in the body? Take a example, somenone says that dose the child DMSA or some other chelating agents to heavy metal,exploding the antimony compound in body, then take urine for medical examination. So using a scientific and authoritative method to test is really important.
    2.Which hospital or research institute is more powerful in antimony compound test?
    These answers need we find out. If you can tell me some information, I will appreciate very much!
    My Email is: wuxufreedom@gmail.com

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  18. Wu Xu,

    I am not sure of the answers to your questions. I think you can test for recent antimony exposure using a urine test but that will only show recent exposure. And, as you point out, if the antimony is sequestered somewhere in the body it would be harder to detect.

    I would suggest talking to your child's doctor to see if they could help.

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  19. Thanks a lot for MJ reply me so quick. Is there someone else can supply some information about an influential and professional hospital or institute to test antimony? Please send me an email if you know, appreciate very much!

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  20. 1. Children's Hospital Birmingham Alabama (toxicologist-Erica Liebelt MD)
    2. Also, be sure to contact Centers for Poisons (ATSD registry) in your state.
    3. Dr. Nachman Brautbar in Los Angeles, CA is another toxicologist but is out until Nov.

    It has been told me that the FDA is not really agressive in safety testing as they could be because they .do not regulate dietary supplements,etc. However, they are responsible for taking enforcement. This is why it is so important to contact your state's Centers for Poisons. Do not keep this issue in the DAN'S office.
    Toxicologists have the testing and experience the DAN doctors lack.
    Note: nothing against our DAN doctors, but this has to be reported ASAP.

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  21. 4. Atlanta Toxicology Clinic
    (404)616-4403 is another source for pediatric toxicologist since Dr. Liebelt may not see unless it is in hospital or a personal favor from your doctor.

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  22. Recall was in Jan/Feb time is an important factor!!! (statue of limitations)

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  23. I appreciate sickandtired's information, and I am think what should I do with them. Or if you have further suggestion , no matter waht aspects, can tell me directly. Thank you again!

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  24. o my gosh! i was so close of buying a trial of chewable vitamin c tablet from kirkman lab and some other multivitamin. howver, after reading your post and commnents, i changed my mind. i really want to try their products but i don't know if i can after the recall. as you pointed out, they're a good company but how can you trust them again? it's just hard.

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  25. CJ,

    I believe it is safe to use their products. My daughters take a Kirkman vitamin C product everyday (among others) and haven't had any problems. Kirkman is still a good company and they seem to have gotten their act together

    I would give them a try.

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  26. I'm with MJ -- and I'm back to using quite a number of Kirkman's products. They know they screwed up big time, and are likely not to do it again. I think they know if they ever do get so careless again, God forbid, they'd have so much law come down on them it would put them right out of business. My husband would see to that -- that's for sure!!

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  27. good news for kirkman. not good for our kids. sorry, i have a different opinion along with hundreds of other parents. i find it too interesting mj and cj go to great lengths to protect a company that fails to list ALL ingredients on their labels. this is not the only autism blog as i am getting very suspicious of this one.us I dont know too many parents defending a large company who just poisoned alot of special kids, including mine.us i am SICK AND TIRED of excuses.us

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  28. sorry cj. i meant akzn. i apologize.

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  29. i am not suspicious with akzn's position either. i just disagree and that's why we have discussion blogs. thank u mj for not attacking my posts. goodbye.

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  30. i am not suspicious with akzn's position either. i just disagree and that's why we have discussion blogs. no offence intended. thank u mj for not attacking my posts. goodbye.

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  31. Sickandtired,

    You are certainly welcome to have your own opinion and I would actually encourage you to share yours. However, you can find my support of Kirkman to be "interesting" or "suspicious" as much as you want, but that doesn't really change my opinion.

    My opinion is based on the fact that we have continued to use Kirkman products without any problems and on the fact that my children's doctor continues to recommend their products.

    At the same time, if my children had experienced any problems because of the contamination, I might very well have a different opinion. It is all a matter of perspective.

    I will say that if Kirkman messes up and has issues like this again, I would be very less likely to use their products in the future.

    For the record, I do not have any other concealed or non-disclosed reason to support Kirkman. I do not have get kickbacks from them (and neither does my children's doctor). I do not make any money or receive other forms of compensation from this site.

    Everything on this site was written by me (and only me) in my spare time and represents nothing more than my opinion.

    Now, whether you choose to take what I am saying at face value is entirely up to you, and you are well within your rights to disagree with me.

    And as I said, you are welcome to share your opinion.

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  32. Sickandtired:

    I want to ask you some information. Can you give me your email address?
    My email: wuxufreedom@gmail.com

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  33. I don't comment on here anymore.
    "MJ" is on too many web sites as well defending people who make money off of us "real parents" and disagreeing with alot of frustrated parents who have every right to be concerned and who "really do have children with autism."

    There are only thirty pediatric toxicologist in the US. My doctor's data report vs their specialty lab (which are only five, and the FDA uses them exclusively as well) came out much different.
    After a chelating agent, not from Kirkman, my son's levels were so high we have been on three weeks of a chelating agent 700 mg three times a day.
    Note: their antimony update as to which type of antimony as per my atty "must not have been good result."

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  34. Sickandtired,

    You need to take a deep breath and calm down. I can understand that dealing with something like this - or autism in general - can be extremely frustrating and disheartening. I think I have given you a lot of leeway to say what you feel the need to say and I have gone out of my way to try and explain where I am coming from.

    But it is not acceptable to lash out at other people or to attack me and say that I am not a "real parent". I strongly suggest that you take some time and think about what exactly you think you are doing.

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