Pharmaceutical Business review

Nutricia Recalls Neocate Infant Product

Nutricia North America has contacted customers to undertake the voluntary recall and replacement of one lot of the specialised infant formula product, Neocate. This recall involves a limited quantity of individual cans (approximately 3700) from Lot no. P91877, and does not affect any other Neocate products or lot numbers.

According to Nutricia, Neocate is a hypoallergenic dry powder formula packaged in 14oz 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 company said, it 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 contain protein levels lower than that declared on the label. The affected product has protein level equivalent to 1.75g protein/100kcal – a shortfall of approximately 0.05g protein/100kcal based on the US infant formula minimum requirement of 1.8g protein/100kcal. However, the product continues to meet the minimum guidelines for protein established by the World Health Organisation.

The company has stated that limited formulation concern does not present any immediate risks of injury or other adverse health consequences, longer term consumption might influence the healthy growth curve in certain infants.

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.