Update about Neocate Junior Unflavored


Posted 12.14.12 | Neocate Admin

We have recently received calls from a few families whose children have had difficulties tolerating our Neocate Junior Unflavored product. 

We know the situation has raised some concerns among our community.  We now want to reassure everyone that we have thoroughly evaluated the matter.  We have completed an exhaustive investigation using all available proven testing options for our product and manufacturing facility.  Results indicate no contamination, cross contamination, or changes to the product. 

Specifically,

In consultation with the U.S. Food & Drug Administration and leading experts in food allergies, food science, pediatrics and immunology, we have thoroughly conducted all available tests on retained and returned product samples. 

The tests were conducted internally and also externally by independent, third party laboratories.  Results indicate the product, including the formulation, ingredients and quality, remains the same as it has always been.  These tests also included the following:

  • Rice: Neither leading experts or the FDA are aware of a test for the presence of Rice protein.  We did however test the product for the presence of Rice DNA.  Results confirmed there is no Rice DNA in the product.
  • We also tested for the presence of Prebiotic Fiber (Inulin and FOS), Sugar and Fructose.  Test results confirm that there is no Prebiotic Fiber, Sugar or Fructose in the product.

We also tested our manufacturing and quality assurance processes to ensure no potential factors were overlooked during any of our evaluations.  These assessments confirmed that there were no changes to, or variations in, our quality assurance standards, which are FDA-compliant.  Additionally, there was no evidence of cross-contamination in our production facility, which is a grade D pharma clean room environment that is audited by the FDA and has a positive record.

Our top priority is always the health and safety of the people who rely on our products.  We have ruled out any formula, manufacturing or quality assurance factors and we are urgently working to direct the families toward a successful nutritional solution in partnership with the right clinical experts.

Please contact our Nutrition Services department at 1-800-365-7354 if you have any questions.

Read Comments (8)

  • 2013-01-07 | Donna McGartland

    I know one of these children who are suddenly having problems with the Neocate Junior.  His family has been in touch with others who have the same problem.  12 children in all.  All have the same issue—any cans issued after May 2012.  There is no problem with anything before that time.  PLEASE CONTINUE TO RESEARCH THIS!!!  WHAT ARE THEY GOING TO DO AFTER THE OLD CANS NO LONGER EXIST???

  • 2013-01-07 | Neocate Admin

    While we have conducted the exhaustive product and manufacturing testing detailed in our post, we know families urgently need solutions for their children, and so we are continuing to consult with leading allergy and immunology experts to determine what we can do to help these children. We will provide full updates as they are available to us.

  • 2013-01-07 | Tommy

    Can you please list the independent companies that investigated this and also post their detailed findings for review?

  • 2013-01-09 | Nicole

    I too know families that are being affected. I switched my daughter to Elecare because of her FPIES issues. Truly hope you get this figured out or get some help for these families. Really hope this does not result in death for these poor babies.

  • 2013-01-10 | Stephanie

    Your thorough investigation of these allegations shows, yet again, the quality of your products and customer service. Thank you, Nutricia!

  • 2013-01-11 | Neocate Admin

    For up-to-date information on our Neocate® Junior Unflavored product, please visit the link for more information: http://www.neocate.com/about-neocate/neocate-junior-update/

  • 2013-02-05 | Valarie Marshall

    I understand your companies need to be concerned for liability issues, but we as human beings need to put the concern for these children and adults alike affected by whatever changes have occurred to your product, above all else. I think we all know something changed and you need to figure out what it is and fix it. Whether a supplier has changed or packaging or whatever at the end of the day really doesn’t matter, what does is reproducing this product as it was before may period! If that is what they need to survive then that is what you as a company need to do! That is it, it is not always about profit, sometimes it is simple human decency!

  • 2013-02-13 | Neocate Admin

    We have been in touch with the families about partnering with them and their physician to help find an alternative nutritional solution. I also wanted to share our resource page that details our full evaluation of this situation (http://www.neocate.com/about-neocate/neocate-junior-update). It’s important to note that we did not make any changes to the Neocate Junior Unflavored product, formula or ingredients in 2012. We urge any families with questions or those experiencing any difficulties with any of our products to please contact our dedicated team of nutrition specialists at 1-800-365-7354.

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About Us

Food Allergy Living is a resource for parents of children with food allergies, brought to you by Nutricia, the makers of Neocate. For more in-depth information about our purpose & authors, see our About Food Allergy Living page.