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| |    Consumer Alert from FDA Consumer Alert: Nutramigen Infant Formula Recalled Spanish label's preparation instructions are wrong EVANSVILLE, IND., July 7, 2001 - Mead Johnson Nutritionals is recalling certain batches of Nutramigen 16-oz. powder infant formula and Nutramigen 32-oz. ready-to-use infant formula because the Spanish-language side of the label for both products gives incorrect preparation instructions. The English-language instructions are correct and the product is safe to use as directed in English. If not properly prepared, Nutramigen 16-oz. powder infant formula and Nutramigen 32-oz. ready-to-use infant formula have the potential to cause serious adverse health effects such as seizures, irregular heart beat, renal failure or in extreme cases, death. Symptoms to look for include vomiting, diarrhea, decreased urine output, irritability, decreased activity or sunken eyes. If your infant has experienced any of these symptoms while consuming either of these products contact your pediatrician or health care provider. Infants living in hot climates, as well as those with fever, pre-existing diarrhea, or chronic illness are at increased risk for life-threatening complications. The affected Nutramigen 16-oz. powder product includes the following batch codes: BHC43, BHC44, BJC45, BJC46, BJC47, BJC48, BKC49, BKC50, BLC51, BLC52, BLC53, BMC54, BMC55, BMC56, BAM57, BAM58, BBM59, BBM60, BBM61, BCM62, BCM63, BCM64, BDM65, BDM66, BEM67, BEM68, BEM69, BEM70, BEM71, BEM72, BFM73, and BFM74. The batch codes are embossed on the bottom of each can. The affected Nutramigen 32-oz. ready-to-use product includes the following batch codes: MBM90, MBM91, MCM92, MCM93, MCM94, MDM95, MDM96, MEM97, MFM00 and MFM01. The batch codes are embossed on the top of each can. Both Nutramigen product forms, 16-oz. powder and 32-oz. ready-to-use, were distributed nationwide, as well as in Guam, the Dominican Republic and Puerto Rico. There have been no reports to Mead Johnson from consumers or health care professionals about any infants who have become ill as a result of these labeling errors. Consumers who have cans of product from these batches may return the product to the place of purchase for a full refund or use the following preparation instructions. For Nutramigen 16-oz. powder consumers should mix one packed level scoop with each 2 fl.oz. of water. For Nutramigen 32-oz. ready-to-use formula pour directly from the can and do not add water. Consumers with questions regarding the recall can call the Mead Johnson Nutritionals Customer Resource Center at 1-800-718-7725. New 7/01 (c) 2001 Mead Johnson Nutritionals. All rights reserved. Contacts: Pete Paradossi Mead Johnson Nutritionals 812/429-7413 Susan Wedeking Public Affairs 812/429-5674 | |  | |||||||||||||||||||||||||||||||||||||||||||||||||
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