ODA Food Safety
Specialists, and Other Interested Parties
Subject:
Recall Announcement (ODA/ODH)
(2001-19)
Date:
July 9, 2001
Nutramigen® 16-OZ. Powder
Infant Formula and Nutramigen® 32-OZ. Ready-To-Use Infant Formula
Recalled Due
To Spanish-Language Labeling Error That Could Result in
Adverse Health Affects Product is Safe When Prepared Correctly
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.