December 2, 2023

FDA Update on Similac Cronobacter Investigation Reveals No Match

The FDA has updated the Similac Cronobacter investigation  and reports that there is no match between the environmental samples of Cronobacter found at Abbott Nutrition’s Sturgis, Michigan plant and the two patient samples the CDC received and tested. In all, four infants were sickened with Cronobacter infections after allegedly consuming powdered infant formula produced by Abbott Nutrition. Two infants who lived in Ohio died, although the FDA has not determined if Cronobacter had a role in those deaths.

FDA Update on Similac Cronobacter Illnesses Reveals No Match

The FDA states, “Five environmental subsamples collected from the Sturgis, Michigan facility were positive for Cronobacter sakazakii; four were detected by the FDA and one was detected through firm-initiated testing. The positive Cronobacter sakazakii environmental samples at the Sturgis, Michigan, facility have been analyzed using Whole Genome Sequencing (WGS), revealing five different strains of Cronobacter sakazakii. Product samples collected by FDA at the facility were analyzed for Cronobacter by FDA and were found negative.”

No more samples are pending analysis at this time. However, during the FDA inspection, a Form 483 was issued that included four observations at that plant, including issues with process controls to prevent contamination, standing water in the facility, and lack of surface maintenance. The FDA states, “The inspectional observations in this Form 483 do not constitute final FDA determinations of whether any condition was or is in violation of the Federal Food, Drug, and Cosmetic Act or any of its implementing regulations. FDA will take appropriate action in the future – if warranted – as we continue to evaluate the 2022 inspectional findings.”

The CDC has completed laboratory testing on the two clinical samples. The samples were not a genetic match to “the multiple strains of Cronobacter found in the environmental samples obtained from Abbott Nutrition’s Sturgis, Michigan facility or any other clinical isolates in the National Center for Biotechnology Informatics (NCBI) database.”

The FDA is currently working with Abbott Nutrition to assess the impact of the recall and understand production capacity at other Abbott facilities that produce some of the affected brands. The FDA still recommends that parents do not feed their infants recalled infant formulas produced at that plant. The recalled powdered infant formulas have all of this information on their labels:

the first two digits of the code are 22 through 37 and

the code on the container contains K8, SH, or Z2, and

the expiration date is 4-1-2022 (APR 2022) or later.

Symptoms of a Cronobacter infection in infants can include poor feeding, excessive crying, fever, and very low energy. This infection can spawn complications such as necrotizing enterocolitis, sepsis, and meningitis if not treated.

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