Fleet Recall – Recalled Fleet Phospho-Soda Info

fleet-phospho-sodaThis is an update to our May, 2006 recall alert regarding bowel cleansing products associated with kidney failure. In December of 2008, CB Fleet Company, Inc. recalled their over-the-counter colonoscopy preparation drug Fleet Phospho-soda after warnings from the FDA stating that Fleet should not be available as an OTC laxative prep for colonoscopy.

The FDA warnings came after several patients developed kidney problems (renal failure) called acute phosphate nephropathy. In acute phosphate nephropathy, calcium-phosphate crystals deposit in the renal tubules causing permanent kidney damage. This can result in the need for life-long dialysis.

Due to the risk of acute phosphate nephropathy, the FDA has determined that over-the-counter laxative oral sodium phosphate (OSP) products such as Fleet Phospho-Soda should not be used for bowel cleansing.

Immediately after the FDA warning, C.B. Fleet Company announced a recall of their OTC products Fleet Phospho-soda® and EZ-Prep Bowel Cleansing System®. Fleet Phosphasoda contains oral sodium phosphate, which was approved by the FDA for OTC use as a laxative. However, Fleet promoted their laxative for use at very high doses as a bowel prep without adequate warnings about the potential risk for kidney damage for years prior to the recall. Some patients, especially those with known kidney disorders, may have been able to avoid potentially life-threatening acute phosphate nephropathy if proper warnings had been provided.

If you have taken OTC Phosphosoda in preparation for a colonoscopy, radiological procedure or surgery, and have developed kidney problems, contact your doctor immediately to discuss a possible link. You may also have legal rights to compensation for your permanent injury.

About

Everett Sizemore is the owner and Editor of US Recall News: http://www.usrecallnews.com. He is dedicated to educating people about consumer safety, social activism and corporate responsibility by bringing information to Americans about the products they use every day.

There are 6 comments. Add yours.

  1. lesa corley

    I have been very ill.for sometime now three long years.Iam a51 years old and have suffered day and night pain I thought I could never live through .I Have been diag/with fibromylja treatmentnow I have renal railure,Good Luck……lesa

    Reply
  2. Phillip Dauzat

    I was given a prep kit in December 2009. I was not told of yhe recall. This prep kit was issued to me by a State Hospital. If I would have known of the recall I would not have taken it.

    Reply
  3. Jill

    I am very interested in Beverly’s post. I also experienced high fever (104 degrees) and chills within 10 minutes of taking Phospho-Soda. The high fever lasted several days, and it was a week before the fever was completely gone. That event was seven years ago. Whenever I have told doctors about this reaction, they all look mystified and assume that I must have had a coincidental illness like flu. None mentioned the recall. Now I am seeing a nephrologist for a definitive diagnosis of what is probably stage 3 chronic kidney disease.

    Reply
  4. VALERIEPE@YAHOO.COM

    MY HUSBAND TOOK FLEETS FOR COLONOSCOPY IN 2003, HE HAD A KIDNEY STONE IN HIS RIGHT KIDNEY, PAIN THEY COULDNT FIND, AFTER THE COLONOSCOPY HE WOULD BECOME VERY ILL AND BEDRIDDEN WITH PAIN IN HIS KIDNEYS AND THIS WENT ON AND ON ANOTHER COLONOSCOPY IN 2005 WOULD SHOW A REPEAT ILLNESS AND LOTS OF KIDNEY STONES WOULD FOLLOW EVENTUALLY DESTROYING HIS BOWELS AND HAS TOTAL BLADDER RETENTION. HE SELF CATHS AND ISNT LOOKING FORWARD TO DIALYASIS AND OR PERMANANT CATH, WICH BECOMES VERY DANGEROUS WITH INFECTIONS. WHEN YOU TOUCH HIS BACK HIS KIDNEYS ARE COLD . AND HIS LIFE HAS BEEN NOTHING BUT SUFFERING EVER SINCE. MY HUSBANDS HEALTH WAS A OK EXCEPT FOR ONE KIDNEY STONE WHEN HE WAS 20. AT 37 FLEETS TOOK HIM DOWN. IN 2008 PREPARING FOR ANOTHER COLONSCOPE DUE TO HEMMORAGING I CALLED THE DOCTOR AND REMINDED THEM THAT MY HUSBAND HAS A KIDNEY DISEASE MUDULARRY SPONGE KIDNEY[ PERSON PRONE TO STONES. ] THAT DEVELOPED AFTER THE FIRST SCOPE. SHOULD HE STILL TAKE THE FLEETS? THEY SAID YES. BUT MY HUSBAND WAS LEARY AND ONLY DRANK ENOUGH TO HAVE ONE OR TWO BOWEL MOVEMENTS INSTEAD OF TWENTY. SO YES IF IT DIDNT KILL YOU IMMEDIATLY PLAN ON SUFFERING THE REST OF YOUR LIFE. FEEL FREE TO CONTACT ME AT MY EMAIL . I HAD TO FIGURE THIS OUT MYSELF AND THE DOCTORS DONT WANNA HEAR IT. THERES BIG MONEY IN DIALYASIS YA KNOW AND ITS CREATING MORE JOBS FOR PEOPLE EVERYDAY GOOD LUCK EVERYONE. THIS ALSO DISABLED HIM AS A WELDER WHO LOVED SUPPORTING HIS FAMILY OF 5. OUR YOUNGEST FROM AGE 5 HAS KNOWN NOTHING EXCEPT MY DADDY IS SICK AND MY MOMMY HAS TO WORK VERY HARD TO TAKE CARE OF US. I LOOK BACK NOW AND KNOW WHAT HAPPENED TO RICHARD?

    Reply
  5. Beverly Olson

    Have you heard of any other symptoms from the product? I had a terrible adverse reaction that included fever within minutes, chills, vomiting, etc. I have not had kidneys checked since taking product. Do the kidney problems occur immediately or do they occur much later?

    Reply

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