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Caraco Digoxin Recall Issued March 31, 2009 Is Due To Pill-Size Problems

Digitek Brand Of Generic Digoxin Tablets Had Been Recalled In April 2008 For Same Reason

(Posted by Tom Lamb at DrugInjuryWatch.com)

On March 31, 2009 the FDA announced another generic digoxin pill recall by posting this company press release on the agency's web site: "Caraco Pharmaceutical Laboratories, Ltd. Announces a Nationwide Voluntary Recall of All Lots of Digoxin Tablets Due to Size Variability".

This March 31 press release from Caraco, a generic pharmaceutical company, states that:

[A]ll tablets of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011, are being voluntarily recalled to the consumer level. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin."

Almost a year ago, in late April 2008, all digoxin pills manufactured by Actavis Totowa — marketed under the Digitek brand name — were recalled due to this so-called "double-dose" manufacturing problem.  Those Digitek pills were distributed by Mylan Pharmaceuticals under the Bertek and UDL labels.

The Digitek recall has resulted in personal injury and wrongful death lawsuits being filed on behalf of patients who used Digitek digoxin tablets.

It is too early to tell whether there will be any product liability litigation involving the possible "double-dose" digoxin pills that are now being by Caraco Pharmaceutical.

P.S.  Read about a "new" May 11, 2009 digoxin recall by a company that repackaged Caraco digoxin tablets – which were originally recalled in late March 2009. 

Why did AS Medication Solutions delay their digoxin recall notice for six weeks?  (5/13/09)

12 responses to “Caraco Digoxin Recall Issued March 31, 2009 Is Due To Pill-Size Problems”

  1. Private Investigator Avatar
    Private Investigator

    This seems to have become a regular trend in the pharmaceutical industry. Isn’t it better that a stringent quality control procedure be implemented before launching itself?

    Reply
  2. Tom Lamb Avatar
    Tom Lamb

    To Private Investigator:
    You are correct; there has been a series of quality control problems involving several generic drug manufacturers in the past 12 months. For a collection of my articles about those various problems during that period see:
    http://www.drug-injury.com/druginjurycom/generics-efficacy-safety-gmp-quality-control/
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  3. Carmine Corvasce Avatar
    Carmine Corvasce

    I have been taking DIGOXIN 0.25MG for many yers wath can I do now?

    Reply
  4. Tom Lamb Avatar
    Tom Lamb

    Carmine:
    If necessary in order to get a different type of generic digoxin pill from the pharmacy, you should contact the doctor who prescribed the Caraco digoxin tablets.
    Given how recent this Caraco digoxin recall is, however, be prepared for the possibility that your doctor’s office has not learned about it, yet. In that situation, you may want to send them a copy of the company press release which is on the FDA web site:
    http://www.fda.gov/oc/po/firmrecalls/caraco03_09.html
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  5. Michael Turrie Avatar
    Michael Turrie

    I have switch to a new provide for my digoxin in January 2009. The drug was made by Caraco Pharm. I started it and at the time became very ill. Symtoms were dizzy spells low blood pressure.Ihad the most severe case of diarrha since. I have been mostly inhome with these problems. I have seen three doctors and have not had any results. I am schuduled for a colonostopy on the 13th of April which I have now canceled. I was called by my priscription provider this AM and told I have to not take my Digoxin. This has been the worst 3 months I can remember.
    Hope things will improve in the near future.

    Reply
  6. whones Avatar
    whones

    I have a family member who had a massive stroke last month. They were taking .125 of Digoxin daily. When she arrived at the hospital they said she was in A-Fib. I just received word today of this recall. Her Rx did come from Caraco and within the time frame specified. Thoughts?

    Reply
  7. Tom Lamb Avatar
    Tom Lamb

    Whones:
    As we did with the Digitek digoxin recall, our firm is investigating possible legal compensation cases that involve a hospitalization or death where there is documented digitalis / digoxin toxicity (by blood test) or where the person had medical symptoms consistent with an overdose of digoxin, or digoxin poisoning, which could have resulted from taking the oversized / “double-dose” Caraco digoxin pills.
    In more detail, some those medical conditions that can result from taking too much digoxin are very low blood pressure, cardiac instability, and bradycardia (slow heart rate).
    If you think the case which you described fits this criteria, you can call me on our toll-free number (800-426-9535) or you can fill out our Digitek Case Evaluation form (use the link below) and indicate that your case involves the recalled Caraco digoxin pills:
    http://www.druginjurylaw.com/DigitekEvaluation.html
    We wish your family member the best in all aspects going forward.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  8. nyla Avatar
    nyla

    I had th esmae problems since I started the new bottle of my medication and was hospitlaized and doctors did not fine anything, I stopped the medication when I got a letter from my pharmacy and have been doing fine since.

    Reply
  9. John Harper Avatar
    John Harper

    My father was notified approximately 6 weeks ago by his pharmacy that his Caraco brand of Digoxin had been recalled due to “wrong strength”. He had been taking that prescription for 2 weeks prior to being notified, and his health and continually worsened (dizziness, short of breath, irregular heartbeat, etc). Even after being switched back to the correct dosage, his symptoms have persisted. His Dr. has been testing his blood regularly and the levels of digoxin in his blood are still elevated way beyond what they should be so. His Dr. has now stopped the medication altogether. Unfortunately, it has also thrown his thyroid (he takes synthetic thyroid medication) and breathing meds out of balance.
    In short, his health continues to deteriorate after 6 weeks of stopping the medicine. What do you suggest we do, and are you aware of a class action suit against Caraco at this point? My family is concerned that if things are not brought under control very soon, he may not survive.

    Reply
  10. Tom Lamb Avatar
    Tom Lamb

    John:
    Your first priority, of course, is your father’s health. As I am only an attorney, and not a medical doctor, I cannot offer any help on that aspect.
    On the legal side of things, as we did with the earlier Digitek digoxin recall, our firm is investigating possible
    Caraco digoxin side effect cases that involve a hospitalization or death where there is documented digitalis / digoxin toxicity (by blood test) or where the person had medical symptoms consistent with an overdose of digoxin, or digoxin poisoning, which could have resulted from taking the oversized / “double-dose” Caraco digoxin pills.
    Anyone with a possible Caraco digoxin side effect injury or death case can call me on our toll-free number (800-426-9535) or you can fill out our Digitek Case Evaluation form (use the link below) and indicate that your case involves the recalled Caraco digoxin pills:
    http://www.druginjurylaw.com/DigitekEvaluation.html
    We wish your father the best in all aspects going forward.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  11. Jennifer Avatar
    Jennifer

    My grandpa was taking Digoxin for several years prior to his death this past June. His cause of death was hyperkalemia and acute renal failure. The physician at the hospital stated that his digoxin medication was the likely cause of his kidneys shutting down. While taking the medication he was constantly experiencing dizziness, irregular heart beat, and was short of breath. His primary care physician and cardiologist were both aware of the fact he was taking digoxin and never suggested he take something else. I’m not a person who believes in suing everyone for anything just so they can get money, but I do believe my grandfather’s death could have been avoided had he not been taking the digoxin medication. Should my grandma consult a lawyer in our town for a possible wrongful death case or is it even worth our time?

    Reply
  12. Tom Lamb Avatar
    Tom Lamb

    Jennifer:
    To start, I am sorry for your loss.
    For this death to possibly be related to your late grandfather’s use of the Caraco digoxin pills that may have had too much active ingredient (and could, therefore, result in an overdose, or digitalis toxicity), he would have been taking those pills up until the day or two the doctor at the hospital made his remark about the digoxin causing the medical problems.
    For this to be the case, however, he would have had to gotten a 90-day supply of the Caraco digoxin pills in March 2009, before the March 31 recall announcement. You can inquire with the pharmacy where he got his digoxin prescription filled to see if this occurred.
    If your grandfather did have a supply of Caraco digoxin pills that he was taking up until the time of his death, this is a possilbe wrongful death case that we would like to investigate furhter.
    I hope this information provides some guidance for you.
    Tom Lamb

    Reply

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