August 8, 2002

POSITION STATEMENT

Change to the preparation instructions on the label for powdered Neocate infant formula
In response to the advice issued by the FDA to Healthcare Professionals on Enterobacter sakazakii ^[1], our parent company, Numico, has instructed Nutricia to change the labels of all powdered infant formulas for use from birth onwards. To protect infants against E. sakazakii and other opportunistic bacterial pathogens, the labeling now recommends that Neocate should be used immediately after preparation.

Nutricia has removed the recommendation from the label that Neocate can be prepared in advance and stored under refrigerated conditions for up to 24 hours. Dilution instructions for the preparation of larger volumes of feeds have also been removed.  

Neocate is produced under strict hygienic conditions and complies with microbiological standards for the production of infant formula. However the following guidelines should be adhered to when preparing and administering Neocate:

• Reconstitute Neocate powdered infant formula with cooled previously boiled water;
• Prepare only a small amount of reconstituted formula for each feeding to reduce the quantity and time that formula is held at room temperature for consumption;
• Minimizing the holding time, whether at room temperature or while under refrigeration, before a reconstituted formula is fed; and
• Minimize the "hanging time" (i.e. the amount of time a formula is at room temperature, in the feeding bag and accompanying lines during enteral tube feeding). 

We cannot recommend a maximum holding or hanging time since other factors will influence this e.g. the standard of hygiene used during feed preparation. Feeds should be freshly made and promptly delivered.

For additional information, please contact Heather Kelley 1-800-365-7354 ext. 265.

^[1] Health Professionals Letter on Enterobacter sakazakii Infections associated with the use of powdered (dry) infant formulas in neonatal intensive care units. US Food and Drug Administration, April 11, 2002.