Neocate Infant Formula Recalled, Reduced Protein Levels to Blame

About 3,700 cans of Neocate brand infant formula have been recalled because a manufacturing error caused the products to contain lower protein levels than is declared on the label, the Food and Drug Administration said.

Nutricia North America, Inc., the maker of Neocate infant formula, said only individual cans from Lot # P91877 are affected by today’s recall. Other Neocate-brand formulas or lot numbers are not affected, officials said.

The recalled cans of infant formula were distributed to locations nationwide between September 1 and September 11, 2009, the FDA said. The lot number can be found on the bottom of each can and on the right hand side of the case label.

Neocate is a hypoallergenic dry powder formula that is commonly given to infants who are under the care of a physician. It is not intended for general use in otherwise healthy infants.

Manufacturing Error Blamed for Defect

A one-time blending error during production of Neocate formula resulted in cans from the recalled lot containing protein levels that are lower than what is declared on the labeling, the FDA said. The defective cans have a reduced protein level equivalent to 1.75 g protein/100kcal, which is about 0.05 protein/100kcal lower than it is supposed to be, officials said.

Officials said Nutricia has taken appropriate corrective measures to ensure that the blending error which led to the improper protein levels in some cans of Neocate formula will not occur in the future.

No Reports of Injuries

There have been no reports of injuries associated with the recalled cans of Neocate formula and the FDA said consuming the defective cans on a short-term basis likely would have no immediate effect. However, longer term consumption might negatively influence the growth of certain infants, the FDA said.

Consumers who have cans of Neocate formula from Lot # P91877 in their possession are advised to contact the Nutricia North America Customer Helpline at 1-800-365-7354, option 8-6061. The company 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, the FDA said.

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