March 2003

FDA Import Alert - KetoCal

We are writing to inform you that our product KetoCal is currently subject to an FDA Import Alert.

The alert relates to an ongoing inquiry by the FDA into the analytical methodology used for determining the level of carbohydrate in KetoCal. Both Nutricia North America and our parent company, Nutricia International Ltd. in the United Kingdom which developed KetoCal and now manufactures the product, are confident that our methodology is appropriate. We have consulted external analytical laboratories, who support our position, and we are currently working with the FDA to resolve the issue.

Nutricia is confident that KetoCal is fit for the purpose of managing Intractable Epilepsy, and that the nutritional specification of the product fully matches its label claims. However, the Import Alert means that KetoCal is not available for distribution at present, so we are writing to notify you of the situation in case you need to consider an alternative dietary regimen for your patients in the short term.

Nutricia is committed to resolving this issue, and continue to give the absolute top priority in order to restore the supply of KetoCal as soon as possible. We will contact you again as soon as KetoCal is once more available. In the meantime, if you have any queries please call Jennifer Devaney, Product Manager on 1-800-365-7354.

Yours sincerely,

Nutricia North America
B.G.A. Gill, President