FDA, CDC, and health officials in Missouri and Illinois are investigating at least two cases of Cronobacter sakazakii (once known as Enterobacter sakazakii) – a rare, but often fatal, cause of meningitis that most often affects newborn babies.
Two Missouri infants have died – 10-day old Avery Cornett of Lebanon, and a one-month old baby girl in Granite City – and an Illinois infant is recovering from the infection.
At least one of the three infected babies is known to have been fed Enfamil Newborn Formula (12.5-oz cans; Lot #ZP1K7G), a product of Mead Johnson Nutrition.
Mead Johnson Nutrition released the following statement yesterday:
December 22, 2011
Our company recently became aware of an infant’s death in Missouri. This infant tested positive for Cronobacter, which is a microorganism commonly found in the environment and sometimes implicated in rare but serious illnesses in newborn babies. We were informed that the infant had been fed one of our products.
The product – Enfamil PREMIUM® Newborn powdered formula – has not been recalled, but is being tested by the U.S. Food and Drug Administration (FDA) with our assistance. All of our finished infant powdered products (including this batch) are tested for Cronobacter (Enterobacter sakazakii) prior to shipment. If an ingredient or a batch of powdered infant formula product is found to contain Cronobacter, it is rejected and not distributed.
The batch of the product used by the child’s family did not show the presence of the bacteria when it was produced and packaged, and that has recently been reconfirmed from our batch records. This product is not being recalled – nor is any other Mead Johnson product – but some retailers are removing it from their shelves as a precautionary measure. The product is Enfamil PREMIUM Newborn 12.5 ounce powder with number ZP1K7G on the bottom of the can.
We recognize that recent media stories may cause confusion and we apologize for that. We want to make every effort to keep our customers informed on any topics related to our products.
We are working with health authorities to support their efforts to identify the source or cause of the infant’s infection. All the employees at Mead Johnson Nutrition wish to extend our heartfelt sympathy to the family.
If you have any questions please contact us at 1-800-BABY-123.
Although the investigation is still in progress and Mead Johnson has not recalled the powdered baby formula, a number of retailers, including Walmart and Price Chopper, have removed the suspect product from store shelves until FDA and CDC complete their studies.
This is not Mead Johnson’s first brush with Cronobacter (formerly Enterobacter) sakazakii. In 2001, a hospital outbreak of Enterobacter sakazakii was traced to a contaminated batch of Portagen powdered infant formula, used to feed babies in the neonatal intensive care unit of a Tennessee hospital. The investigation into the causes of that outbreak led to changes in FDA’s recommendations for the preparation, use, and storage of reconstituted powdered infant formula.
FDA has collected – and is in the process of analyzing – several samples of the infant formula and the water used to reconstitute the formula from the Lebanon, Missouri and the Illinois cases, according to FDA Spokesperson Siobhan DeLancey.
“This is a tragic case,” DeLancey said, “and we are working as quickly as possible to investigate all the avenues by which the baby could have been infected.”
“It is important to note,” DeLancey adds, “that at this time there is no confirmation that either infant’s infection was caused by the infant formula or the water used to reconstitute it.”
FDA estimates that its test results will be completed by the middle or latter part of next week. And I’m told by CDC’s Lola Russell that genetic profiles (PFGE profiles) of the bacteria recovered from the infected babies also may be available next week. CDC expects that the complete investigation, including environmental test results, could take up to one month.
The Illinois Department of Public Health has issued the following recommendations to consumers who use powdered infant formula:
- Wash hands, forearms and fingernails thoroughly before handling any feeding materials or preparing formula.
- All bottles, nipples, caps and rings should be washed in hot, soapy water with thorough rinsing.
- Before use, powdered formula should be kept dry in an airtight container with a firm cap or lid and stored in a cool, dark area. Make sure the expiration date has not passed.
- During formula preparation, bring water to a bubbling boil for two minutes and allow the water to cool before mixing.
- Do not use a microwave oven to warm the formula.
- Formula should be prepared in small amounts immediately before feeding time to minimize the need for storing reconstituted formula.
- Reconstituted formula should not be stored at room temperature for more than one hour or more than four hours in the refrigerator after preparation.
- Throw out any formula left in a bottle after feeding.
Readers can find more information on Cronobacter (Enterobacter) sakazakii – including its connection with powdered infant formula and meningitis in infants – in my book, Food Safety: Old Habits, New Perspectives, published in 2007 by ASM Press.