Supervalu Inc., Walgreen Co., Kroger Co. and Safeway have decided to clear their shelves of 12.5 ounce cans of Enfamil Premium Newborn formula, lot number ZP1K7G. This comes after the mega-giant retailer, Walmart, removed the infant formula from the shelves of over 3,000 stores last week.
This particular batch of Enfamil has come under scrutiny after a 10 month-old infant in Missouri allegedly consumed the formula before he became sick and died.
Preliminary tests show he developed a rare infection from Cronobacter sakazakii, a bacteria that has previously been found in powdered infant formula. Thus far, health officials have not confirmed that the formula in question was the source of the baby's infection.
The stores that have pulled the formula say that they are reacting out of caution.
Other stores are expected to follow suit. SuperValu spokesman Mike Siemienas told ABCNews.com on Friday. "We will hold these products from sale until we receive additional guidance from regulatory authorities and the manufacturer."
Kroger officials told the Associated Press that they withdrew the formula from properties in Arizona, Indiana, New Mexico and the mid-Atlantic region.
Walgreen Co. spokesman Jim Cohn confirmed that the company's stores have pulled the formula from store shelves, though he said it was unclear how many stores would be affected under the directive. "We are awaiting further clarity from the manufacturer and FDA."
Health officials say customers who purchased the formula should discard it or return it to the store.
Samples of the formula were sent to the Center of Disease Control and Prevention (CDC) for testing.
The FDA says that so far "they don't have anything that indicates this is linked to Enfamil." The agency is testing samples from an open packet of formula that was fed to the infant, and the water that was used to mix the formula. Results should be available next week.
The infant that died was the second infant to develop a Cronobacter sakazakii-related infection in a Missouri hospital in the past month, the department said on its web site. The second infant recovered.
A spokesman for Mead Johnson Nutrition, the manufacturer of Enfamil formulas, said on Thursday that the company routinely tests its formula for Cronobacter.
"The batch of our product used by the child's family tested negative for Cronobacter when it was produced and packaged, and that has been reconfirmed from our batch records following this news," he said.
Cronobacter sakazakii, once known as Enterobacter sakazakii, is a bacteria found in powdered infant formula as well as in plant material and the environment, according to CDC.
Infant formula has been the cause of several documented cases of Cronobacter sakazakii infection worldwide. The fatality rate in infants is considered very high.
According to the World Health Organization (WHO) the bacteria might be introduced in the formula in three different ways: Through the raw ingredients before production, through contamination after pasteurization and through contamination during preparation of the formula by caregivers.
Referring to published case studies, Schaffner said many of the infants became ill because the formula wasn't prepared properly. Powdered infant formula is not sterile and must be handled carefully to avoid contamination.
"Caregivers sometimes haven't followed the instructions very meticulously," he said.
"Sterilize bottles, spoons and nipples in boiling water. Infant formula should be freely prepared for each feeding, and remaining milk should be discarded. Water should be boiled and allowed to cool before preparing the formula," Schaffner explained.
Cronobacter sakazakii can cause a condition in which the intestinal lining dies off. Symptoms include bloody stool, diarrhea, vomiting, lethargy and intolerance to feeding.
Customers can exchange Enfamil Newborn formula in 12.5-ounce cans for another brand or get a full refund.
Mead Johnson Nutrition Co. said the tests it conducted on samples of its Enfamil baby formula ,tied to an U.S. Food and Drug Administration investigation, found no presence of bacteria. The company called the product safe.
The samples matched those being tested by regulators and, using their methods, found no Cronobacter Mead Johnson said in a statement.
The Enfa brands, which include Enfamil, accounted for 79 percent of Mead Johnson’s $3.14 billion in 2010 revenue and were the world’s lead brand franchise in pediatric nutrition based on retail sales, the Glenview, Illinois-based company said in a February filing.
The company said all of its infant formula products undergo more than 2,300 quality tests and checks to ensure they meet standards set by the World Health Organization and FDA.
Source: http://www.enfamilalerts.com/
http://abcnews.go.com/Health/enfamil-off-shelves-retailers-pull-product/story?id=15224102&page=2#.Tvfp-5gzJnY
