Abbott Nutrition is recalling a batch of Similac PM 60/40 powdered infant formula due to another report of a dangerous bacterial infection.
The Food and Drug Administration said in an update Monday, Feb. 28, that health officials were investigating an additional illness of Cronobacter sakazakii with exposure to powdered infant formula produced at the company’s Sturgis, Michigan facility.
That baby also died of Cronobacter.
“The most recent patient was reported to have consumed Abbott Nutrition’s Similac PM 60/40 product with the lot code 27032K800 prior to Cronobacter sakazakii infection,” the FDA said.
The Centers for Disease Control and Prevention and the US Food and Drug Administration are investigating reports and complaints of infant illness related to formula from Abbott’s facility in Sturgis, Michigan.
Abbott said in an update Monday that in addition to the other formula recalled it was recalling Lot #?27032K80 (can) / Lot # 27032K800 (case) of Similac PM 60/40 after learning of the baby’s death.
Other products previously recalled include Similac, Alimentum and EleCare powdered infant formulas.
“This case is under investigation, and at this time the cause of the infant’s Cronobacter sakazakii infection has not been determined,” Abbott posted on its recall website. “We want to extend our heartfelt sympathies to the family.”
Abbott also said “no distributed product has tested positive for the presence of Cronobacter sakazakii” and recently tested retained product samples of Similac PM “were negative for Cronobacter.”
The FDA said its investigation with the Centers for Disease Control and Prevention now includes four reports of Cronobacter sakazakii infections in infants and one complaint of a Salmonella Newport infection. All of the babies were hospitalized and Cronobacter may have contributed to death in two patients.
The FDA said it is “working with Abbott Nutrition to better assess the impacts of the recall and understand production capacity at other Abbott facilities that produce some of the impacted brands.” The FDA also said it is working with Abbott “on safe resumption of production at the Sturgis, MI facility.”
Cronobacter sakazakii is a germ found naturally in the environment and can live in very dry places. The germs can live in dry foods, such as powdered infant formula, powdered milk, herbal teas and starches. It also has been found in wastewater.
In infants, Cronobacter usually causes sepsis or severe meningitis. Some infants may experience seizures. The mortality rate for Cronobacter meningitis may be as high as 40%, the CDC said.
