Nutricia North America has started a voluntary recall and replacement of one (1) lot of the specialized infant formula product, Neocate. This recall involves a limited quantity of approximately 3700 cans.
The recalled product is isolated to Neocate® Infant Specialized Formula Lot P9187. Neocate is a hypoallergenic dry powder formula packaged in 14 oz. cans distributed to pharmacies, health care professionals and consumers nationwide. Neocate is not intended for general use and is usually given to infants in the care of health care professionals. The affected cans were distributed in commerce between September 1, 2009 and September 11, 2009. 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.
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.
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. However, the affected product from Lot # P91877 continues to meet the minimum guidelines for protein established by the World Health Organization.
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.
source: FDA release
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