Information on Neocate® Junior with Improved Vitamins and Minerals

Dear Neocate Community,

Our sole purpose is to provide specialized medical nutrition to children and adults with highly-sensitive and complex conditions. We periodically improve our products to reflect the latest medical and scientific consensus and ensure that the people who use our products receive the best possible nutritional support for their optimal health. If we receive a report of an individual who is unable to tolerate his or her source of nutrition, we always aim to work closely with the individual’s family and physician to help find a solution that meets the individual’s unique needs.

In February 2013 we improved the levels of 11 vitamins and minerals, like vitamin D, in our Neocate® Junior line of products to provide better nutritional support. The improvements ensure that Neocate Junior products are in line with the U.S. Institute of Medicine’s current dietary reference intake (DRI) recommendations. The upgrade did not alter the macronutrients (i.e., protein, fat, carbohydrate), and the products retain the same hypoallergenic properties as before. Since then, for more than a year, thousands of children have continued to thrive on Neocate Junior with improved vitamins and minerals for their daily nutrition.

We have been working with the family and physician of one child having tolerability difficulties with the upgraded product to support them in finding a solution that addresses the child’s individual medical diagnosis and needs. For this case, we are going to manufacture the pre-upgrade formula that we discontinued in January 2013 for the child’s trialing under supervision from a physician.

This is currently an isolated case, and so we are not marketing the discontinued product. However, we will work individually with any family and their physician who reach out to us and help address concerns or difficulties with our products. This may include transition support, support trialing other commercially available options, and finally working with the child’s physician to determine if any other nutritional solutions might be successful, such as producing a discontinued formulation.

Questions on the 2012 Label Graphics Change

Some families reported concerns with pre-upgrade Neocate Junior following a change to the product label graphics in 2012; however there was no change to the product formulation or process prior to the February 2013 upgrade.

What You Should Do

For most children, moving from one formula to a nutritionally-improved version does not typically require a transition period or present tolerability concerns. Families should continue using the upgraded Neocate Junior with improved vitamins and minerals as directed. All Neocate Junior products are hypoallergenic and safe for use as directed.

If you have questions or concerns, including tolerability issues, we encourage you to contact your child’s physician or our Nutrition Services team (1-800-365-7354), so that we can help support your individual case.

For more information on the upgrade, please (www.neocate.com/about-neocate/neocate-junior-update/)

Kind Regards,

Nutricia North America

 

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