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4.6 million cans of formula recalled over Spanish label error

DAVID HO

WASHINGTON (AP) – Mead Johnson Nutritionals is recalling about 4.6 million cans of powder and ready-to-use infant formula because the cans have incorrect preparation instructions in Spanish that could lead to serious health problems and even death.

The recall by Evansville, Ind.-based Mead Johnson includes about 3.7 million 16-ounce cans of powder Nutramigen formula and about 930,000 32-ounce cans of the ready-to-use version, the company and the Food and Drug Administration said Saturday.

Mead Johnson said it had received no reports of any infants sickened because of the labeling error, but parents should contact a doctor if a child has become ill after eating the product. Symptoms to look for include vomiting, diarrhea, irritability, less urination, decreased activity and sunken eyes.



The formula is intended as a sole food source for infants younger than six months who have certain digestive problems or are allergic to proteins found in milk and other foods, said Charles Mize, a scientist with the FDA’s food safety center.

Adding an incorrect amount of water alters the formula’s precise mixture of nutrients and could cause seizures, an irregular heartbeat and even death if children drink the altered formula for several days, Mize said.



Infants who live in hot climates or are already sick are at greater risk for potentially fatal complications, he said.

Mead Johnson distributed the products nationwide and in Guam, the Dominican Republic and Puerto Rico.

Instructions for using the formula can be found on a two-sided label, with English on the front and Spanish on the back. Consumers have to peel the label off the can to see the Spanish instructions, said Mead Johnson spokesman Pete Paradossi.

The Spanish side provides the wrong preparation steps.

But the English instructions correctly state that the ready-to-use formula should be used without water and the powder formula should be mixed with two ounces of water for each scoop of powder.

The recalled Nutramigen cans are white with blue lettering and have pictures of rabbits on the side. The cans were sold in six-packs and have the following batch codes:

-For powder formula, the bottom of the can reads: 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.

-For ready-to-use formula, the top of the can reads: MBM90, MBM91, MCM92, MCM93, MCM94, MDM95, MDM96, MEM97, MFM00 and MFM01.

The company became aware of the problem after a consumer complained on Tuesday, Paradossi said.

Consumers can use the proper preparation instructions or return the cans to the place of purchase for a full refund. For more information consumers should call Mead Johnson toll-free at 1-800-718-7725 between 7 a.m. and 7:30 p.m. CDT Monday to Friday and on Saturday between 8 a.m. and 4:30 p.m. CDT.

For cans still on store shelves, Paradossi said, the company will place stickers on them telling consumers to ignore the Spanish instructions.

On the Net:

Mead Johnson: http://www.meadjohnson.com

FDA: http://www.fda.gov


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