Mead Johnson Nutrition Co said tests it conducted on samples of its Enfamil baby formula tied to a US Food and Drug Administration (FDA) 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, a kind of environmental bacteria that can be fatal, Mead Johnson said in a statement on Sunday.
Two babies tested positive this month for Cronobacter, including a newborn in Lebanon, Missouri, who died. That prompted retailers, including Wal-Mart Stores Inc, Kroger Co and Walgreen Co, to remove the baby formula from shelves. The other baby became sick, though survived.
Mead Johnson spokesman Chris Perille said the company tested the same batch of formula as public health authorities. The negative test for Cronobacter confirmed results the company got before it shipped the batch of Enfamil Premium Newborn powdered formula.
“We hold samples of every batch,” Perille said in a telephone interview on Sunday. “There’s only one batch of one product that’s being checked out.”
Mead Johnson has not been given a timeframe for when the FDA and Centers for Disease Control and Prevention will finish their reviews, which probably include water samples and other environmental tests, Perille said.
No other “serious” complaints have been reported related to the batch of Enfamil Premium Newborn that’s being tested, he added.
The Enfa brands, which include Enfamil, accounted for 79 percent of Mead Johnson’s US$3.14 billion revenue last year and were the world’s lead brand franchise in pediatric nutrition based on retail sales, the 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 WHO and FDA.