Neocate Infant Specialized Formula Recalled

Nutricia North America, Inc. is recalling one lot of its specialized infant formula, Neocate.
This recall involves approximately 3,700 cans from lot number P91877. This number can be found at the bottom of each can and on the right-hand side of the case label. The affected cans were distributed between September 1 and September 11, 2009. The recall does not affect any other Neocate products or lot numbers.

Neocate is a hypoallergenic dry powder formula packaged in 14-ounce cans distributed to pharmacies, health care professionals and consumers nationwide. The formula is usually given to infants in the care of health care professionals.

Nutricia has been informed by the manufacturer of Neocate that due to a one-time blending error, a limited quantity of the individual cans of Neocate Infant Original Formula contain protein levels lower than that declared on the label. The affected product from lot number P91877 has a reduced protein level equivalent to 1.75 g of protein per 100 kilocalories, a shortfall of approximately 0.05 g protein per 100 kilocalories based on the US infant formula minimum requirement of 1.8 g protein per 100 kilocalories. However, the affected product from lot number P91877 continues to meet the minimum guidelines for protein established by the World Health Organization.

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

Parents, caregivers and healthcare professionals who have questions or concerns related to the affected product should contact the Nutricia North America Customer Helpline at 800-365-7354 and select option 8-6061 Monday through Friday from 8:30 a.m. EDT to 5 p.m. EDT.

Contact:
Meredith Klein
312-233-1236