Abbott is recalling baby formula produced at a Michigan plant following reports that four infants in three states fell ill with bacterial infections.
The company says it took the action after it became aware of four consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants who had consumed powdered formula. According to the Food and Drug Administration, three of the cases, including the death of a newborn, were linked to Cronobacter.
The recall applies to certain formulas under the Similac, Alimentum and EleCare labels, in which the first two digits of the container code are 22 or 37; the code contains K8, SH or Z2; and has an expiration date of April 1 or later. Packages that don’t meet all of those conditions are not affected, according to the company and the Food and Drug Administration.
Abbott is initiating a voluntary recall of powder formulas, including Similac, Alimentum, and EleCare, manufactured in a facility in Sturgis, MI due to complaints of Cronobacter sakazakii or Salmonella Newport in infant consumers of the formula. More: https://t.co/khhSabjQ67 pic.twitter.com/3I6O4YJEnM
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“We want to reassure the public that we’re working diligently with our partners to investigate complaints related to these products” and resolve the safety concern as quickly as possible, said Frank Yiannas, FDA deputy commissioner for food policy and response.
Abbott spokesman John Koval declined to say how many units of formula were being recalled or where they were being distributed. “Our current focus is on communicating with parents, patients and customers―we’ll address the size and scope at a later date,” Koval said.
The four cases occurred in Ohio, Minnesota and Texas. However, FDA press officer Veronika Pfaeffle said the formulas made at the Sturgis facility “can be found across the United States and were likely exported to other countries as well.”
Cronobacter is a bacteria that can cause severe infections, including inflammation of the membrane surrounding the rain and spinal cord, known as meningitis. Its symptoms include poor feeding, irritability, temperature changes, jaundice, labored breathing and abnormal movements. Salmonella can cause digestive illness and fever, commonly presenting itself in the firm of diarrhea, fever and abdominal cramps. Both conditions can be life-threatening for children.
The FDA said an inspection of the Sturgis factory detected cronobacter in test samples. Abbott said the positive results came from “non product contact areas,” while the FDA also said investigators made unspecified “adverse inspectional observation.”
The company’s internal records indicate that the company destroyed some product due to the presence of bacteria there, according to an FDA advisory.
Koval, the Abbott spokesman, said all infant formula products are tested for pathogens including cronobacter and salmonella, and any product has to test negative before it can be released. The company has not found traces of either bacteria in finished product, he said.
Abbott said consumers can visit similacrecall.com to check whether their supplies are included in the recall or call 800-986-8540.
“We’re taking this action so parents know they can trust us to meet our high standards, as well as theirs,” Joe Manning, executive vice president for nutritional products at Abbott, said in a statement. “We deeply regret the concern and inconvenience this situation will cause parents, caregivers and health care professionals.”