Heparin Recall Lawsuits: FDA identifies contaminant

Harvey Kirk

By Harvey Kirk
Posted March 8, 2008


The FDA found an unidentified contaminant in batches of the recently recalled Baxter heparin, which could be responsible for causing severe allergic reactions in nearly 800 people. Heparin recall lawsuits are being reviewed by the lawyers at Saiontz & Kirk, P.A. for individuals who have suffered a severe complication or death after receiving the bad blood thinner.

>>INFORMATION: Heparin Recall Lawsuits

Starting in November 2007, Baxter began to receive reports of unusual allergic-type reactions associated with the use of their heparin, particularly among those who received large doses of the blood thinner during dialysis treatment or cardiac surgery. On January 18, a partial Baxter heparin recall was issued for nine lots of the blood thinner, and the recall was expanded late last month to include all lots of blood thinner produced at the same plant in China.

>>PRIOR POST (2/29/2008): Baxter Heparin Recall Expanded

As of this week, the FDA indicates that a total of 785 reports of heparin complications have been received, including 19 deaths. However, many hospitals and dialysis centers have not been reporting all of their heparin problems to the FDA, which likely means that the blood thinner reactions are much more widespread.

FDA testing has uncovered substantial quantities of a counterfeit chemical in the Baxter heparin. Although the fake ingredient accounted for between 5% and 20% of the total mass of each sample, the problems were not discovered by Baxter before they distributed the blood thinner throughout the United States. Officials from the FDA suggest that the use of a substitute raw ingredient by suppliers in China could have been have been caused by negligence or for fraudulent reasons.

Similar problems surfaced in Germany this week, leading to a different heparin recall after a spike in reports of heparin complications and allergic-type reactions were discovered by German drug authorities. That heparin, which was made by a German company, also may have contained raw ingredients received from suppliers in China.


The contaminated heparin should have been identified as subpotent by Baxter during their quality tests, which could have prevented individuals from suffering allergic reactions and potentially fatal complications. Baxter heparin lawsuits are being reviewed throughout the United States for problems caused by the bad blood thinner. To determine if you, a friend or family member may have experience complications caused by the recalled heparin, request a free consultation and claim evaluation.

10 Comments • Add Your Comments

  • sharon says:

    My Husband was given heparin for 16 days, three times a day.
    he has suffered terrible rashes and blood problems resulting in very thin blood and causing purple spots all over his body. He was very sick for 7 months or longer . He has scars on his body from the rash he got resulting from the heparin he was given in December of 2007.

    Posted on January 13, 2009 at 3:24 pm

  • Theresa says:

    In January of 2006, I had cardiac surgery to repair two valves and my aorta.I was in a coma for a couple weeks, during which I had a hit attack (allergic reaction to heparin). After I came home from the hospital, I was prescribed coumadin, in which I could not take. My levels could not level out so the doctor had to take me off of it. I ended back in the emergency room once and back in the hospital on a separate occasion.My levels went all the way up to over 7 and all because they couldn’t get my blood right after the hit attack. While I was in the hospital the second time, I had to recieve several pints of plasma to even everything out.I reckon I’m one of the lucky ones because I’m still here and will be for as long as God wills.

    Posted on January 25, 2009 at 8:52 pm

  • Jaiquita says:

    My mother nephew happen to ask a nurse what are some of the allergic reactions to Heparin. He asked because there are signs inside and outside my mothers room saying, “No Heparin” and “no Heparin flush” because the doctors said she had a allergic reaction to it. When the nurse describe what some of the reactions were everything she said and what the internet said about the allergic reaction to Heparin my mother has most of those symtoms. I just found out 2 days ago. Now it make since why they were insisiting for my family to pull the plug or at least rushing her to go to a long term rehab facility quickly.

    Posted on March 21, 2009 at 12:17 pm

  • norbert says:

    On april 11, 2009 , may wife passed away at Knaapp Medical Ceinter in Weslaco , Tx , She was suffering from a very strange illness that started very much with the symptom of involuntary tremors . The doctor made a wrong assessment of her condition and had put her in hospice instead of giving her professional medical attention. I had complained before of the possibility of heprin reaction during her blood transfussions, and the failure of her bard port, which eroded in her chest but nobody listened and , I strongly believe that acombination of Both , led to her death.

    Posted on January 5, 2011 at 11:47 pm

  • jessica says:

    I was given heprin when I developed a blood clot in my adreanal glands in Massachusetts Then the clot turn into an internal bleed around my adreanal glands the hospital sent me home even though I complained of pain in my back vommitig and no energy they said the clot should be taken care of . After thirty days of pain and suffering and a sixty pound weight loss I went to my Primary care doctor whom said if i had not come in that day I would have died. I was still bleeding internally.I was then admidtted, The bleed caused me to have adreanal innsuffiency. I now have to be on steriods for the rest of my life to stay alive, The heprin also left rash like spots that did not heal normally they left scaring.

    Posted on August 3, 2011 at 12:49 am

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