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.
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.
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