Neocate®, specialized infant formula product, is being recalled. Approximately 3,700 cans from Lot # P91877 are being recalled nationwide.

Due to a blending error, a limited number of cans contain protein levels lower than that declared on the label. The affected cans were distributed in commerce between September 1, 2009 and September 11, 2009.

This limited formulation concern does not present any immediate risks of injury or other adverse health consequences. No adverse events have been reported as a result of this issue.

The affected product from Lot # P91877 has a reduced protein level equivalent to 1.75g protein/100kcal - a shortfall of approximately 0.05g protein/100kcal based on the U.S. infant formula minimum requirement of 1.8g protein/100kcal.

Although short-term consumption of product from the affected batch is very unlikely, longer term consumption might influence the healthy growth curve in certain infants.

Recommended Action to be Taken by the User
The affected products have the Lot # P91877; this number can be found at the bottom of each can and on the right hand side of the case label.
Parents, caregivers, and health care professionals who have questions or concerns related to the consumption of the affected product are advised to contact the Nutricia North America Customer Helpline at 1-800-365-7354, option 8-6061. We can be reached during normal business hours Monday through Friday from 8:30am EDT to 5:00pm EDT and for special extended hours 8:30 am EDT to 8:00 pm EDT on Monday and Tuesday, September 28 and 29th.

For more information please visit www.nutricia-na.com or www.neocate.com or contact Meredith Klein, Edelman PR at (312) 233-1236.