On February 28, Abbott Laboratories voluntarily recalled additional cases of Similac PM 60/40 produced at its Sturgis, Mich., facility, after an infant who was exposed to the powdered infant formula died, FDA has reported. The agency noted that the child consumed Similac PM 60/40 and contracted a Cronobacter sakazakii infection, noting the formula may have been a contributing cause of death.
Only 10 days earlier, Abbott recalled certain Alimentum, Similac, and EleCare baby formulas made at the same facility after complaints surfaced about bacterial infections in infants who consumed the products. It also impacted digestively compromised individuals who rely on these products for their entire nutritional intake
As part of an ongoing investigation by FDA and the Centers for Disease Control and Prevention (CDC), four reports of Cronobacter sakazakii infections in infants have come to light, with another complaint of a Salmonella Newport infection in an infant. All five illnesses resulted in hospitalization, and two of the patients died. The FDA and CDC are continuing the investigation and the cause of the infants’ infections has not been determined.
The infant in the most recent death reportedly consumed Abbott Nutrition’s Similac PM 60/40 product with the lot code 27032K800. FDA warns that other Abbott products should not be used if the first two digits of the lot code are 22 through 37; the code on the container contains K8, SH, or Z2; and the expiration date is April 1, 2022, or later.
Abbott released a statement explaining that it conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis and testing for Cronobacter sakazakii prior to release. The company says it found evidence of the bacteria at the Michigan plant in non-product contact areas, but that no distributed product tested positive for the bacteria’s presence.
FDA noted that the recalled Similac PM 60/40 cans and cases have been distributed to the U.S. and Israel, while the original recall impacts Alimentum and EleCare formulas in the U.K. as well. None of the recalls involve liquid formula products, so FDA notes that consumers may continue to use those products and any not included in the recall.
FDA is continuing to investigate. Requests for comment from Abbott Nutrition were not immediately returned to Food Quality & Safety.
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