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Neocate Recalls Infant Formula

Error caused particular batch to have low protein content

September 29, 2009
The maker of Neocate specialized infant formula has recalled nearly 4,000 cans because the product contains protein levels lower than the amount declared on the label.

Nutricia North America, Inc. said this nationwide recall -- triggered by a blending error -- is limited to one specific lot of Neocate® infant (original formula): Lot # P91877.

Neocate is a hypoallergenic dry powder formula that is packaged in 14 oz. cans and distributed nationwide to pharmacies, health care professionals, and consumers. The formula is not intended for general use and is usually given to infants in the care of health care professionals, the company said.

The approximately 3,700 cans of infant formula involved in this recall were distributed 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," according to a written statement on the company's Web site. "No adverse events have been reported as a result of this issue."

The recalled formula 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, the company said.

The company emphasized, however, the recalled formula still meets the minimum guidelines for protein established by the World Health Organization. "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," the company said.

Nutricia is working with the Food and Drug Administration (FDA) on this action and apologized for any inconvenience to its customers.

The company also said it has taken steps to correct and prevent a similar blending error in the future. "Nutricia will continue to carefully monitor the situation and follow-up with its customers to ensure prompt replacement of the affected product," the company said.

Consumers with questions about this action can contact the company at 1-800-365-7354, option 8-6061. Consumers can also find additional information on the company's Web sites, www.neocate.com or www.nutricia-na.com.

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