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Consumer Alert from FDA
Consumer Alert: Allergy Alert Issued for LactoFree Formula Sample Packs
Product not safe for infants allergic to milk protein



EVANSVILLE, Ind., August 3, 2001--Mead Johnson Nutritionals is requesting that physicians temporarily discontinue the distribution of LactoFree® infant formula sample packs and Enfamil® A.R.® infant formula sample packs because they do not list ingredients on the back of the box. Although there is nothing wrong with these products, consumers who received these sample packs are being asked to consult with their physician before using these products. Infants allergic to milk protein run the risk of a serious or life threatening allergic reaction if they consume these products.

The LactoFree infant formula sample packs contain two 3 oz. ready-to-use Nursette® bottles and two Easy One® single serve powder packets. The Enfamil A.R. sample packs contain three 3 oz. ready-to-use Nursette bottles and a single hole nipple. No other sizes or forms of LactoFree or Enfamil A.R. are affected.

The LactoFree and Enfamil A.R. sample packs have been distributed to physicians nationwide. There have been no reports to Mead Johnson from consumers or physicians about any infants who have become ill as a result of this labeling issue.

"While the chances of a child with high sensitivity to milk protein consuming these products may be extremely small, we are unwilling to risk a reaction in even one child who may be hyper-sensitive to milk protein," said Dr. J. Roberto Moran, Vice President, Global Medical Affairs for Mead Johnson Nutritionals.

Physicians or parents with questions can call Mead Johnson Nutritionals at 1-888-222-9223.
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