FDA closes outbreak investigation without finding cause; work continues on others

The FDA reports it has closed an investigation of an outbreak of infections from E. coli O143:H26 without identifying a source of the pathogen.

Investigators from the Food and Drug Administration found 14 confirmed patients in the outbreak, but did not publicly report their ages or states of residence.

The FDA did a traceback investigation in its work to identify the cause of the outbreak, but did not publicly report what foods or beverages were involved. The agency did not conduct any onsite inspections or conduct any sampling or testing as part of its investigation.

In other outbreak news, the FDA added an outbreak associated with infant formula to its outbreak investigation update table. The patient count stands at four infants. In other reports in recent days the agency said three of the babies have been infected with cronobacter bacteria and one with Salmonella. All four babies have required hospitalization and one died. The death is under investigation to confirm the infection was a causative factor.

The infant formula related outbreak has resulted in the international recall of three brands of powdered formula made by Abbott and sold under the brands Similac, Alimentum and EleCare.

The FDA is advising consumers not to use Similac, Alimentum and EleCare powdered infant formulas if:

  • 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.

Other outbreak investigations
FDA investigations into five ongoing outbreaks and the closure of two investigations are listed in the table below.

The table shows information about outbreak investigations being managed by FDA’s CORE Response Teams . The investigations are in a variety of stages. Some outbreaks have limited information with active investigations ongoing, others may be near completion. The table below has been abbreviated to show only active investigations.

The Food and Drug Administration will issue public health advisories for outbreak investigations that result in “specific, actionable steps for consumers — such as throwing out or avoiding specific foods — to take to protect themselves,” according to the outbreak table page.

Not all recalls and alerts result in an outbreak of foodborne illness. Not all outbreaks result in recalls.

Outbreak investigations that do not result in specific, actionable steps for consumers may or may not conclusively identify a source or reveal any contributing factors, according to CORE’s outbreak table page. If a source(s) and/or contributing factors are identified that could inform future prevention, FDA commits to providing a summary of those findings, according to CORE officials.

Click here to visit the FDA page that has a complete list of outbreak investigations and links to outbreak information.

Click on the table to enlarge. Use link above to go to the FDA page with links to specific outbreak information.

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