FDA Probes Death Of Infant Who Consumed Abbott Infant Formula

The U.S. Food and Drug Administration said it is investigating the death of another infant after consuming Abbott Laboratories’ baby formula.

In a statement, the agency noted that the child died in January and the consumer complaint was received on June 10. The investigation is in its preliminary stages and the agency will provide an update as it learns more.

The FDA has previously reported its review of complaints related to nine infant deaths. According to the agency, only two were associated with the Abbott Nutrition Sturgis plant investigation. Despite extensive investigation, the evidence does not rule in or rule out a definitive link between these infant deaths and the product produced at Abbott Nutrition’s Sturgis plant.

Abbott Nutrition, the largest U.S. infant formula manufacturer, had closed its baby formula plant in Sturgis, Michigan after reporting bacterial infections and related deaths in babies. The resultant major recall of its most popular powder formulas had triggered the severe shortage for infant formula supplies in the United States.

Abbott had called back millions of powder formulas, including Similac, Alimentum, and EleCare, produced at the facility after four infants were diagnosed with Cronobacter sakazakii or Salmonella Newport, a rare bacterial infection, including two deaths reported to the FDA between September 2021 and February.

The plant was closed down, and the investigation report by FDA noted that the facility failed to maintain sanitary conditions and procedures.

The FDA also has investigated some 129 complaints associated with Abbott Nutrition formula products to date. Of these, 119 complaints were reported after Abbott’s recall on February 17.

But, following the worst shortage of the baby formula products, Abbott Nutrition reopened its Sturgis plant in early June, as agreed by the FDA, and restarted the production of specialty infant formula, EleCare.

Meanwhile, Abbott had to shut down the plant last week following severe weather and rainfall that resulted in flooding in areas of the Sturgis facility. The FDA said it will return to the facility and work closely with Abbott so as to restart the Sturgis facility as quickly as possible.

Since the recall caused severe shortage, the Biden Administration also has taken various steps to bring as much infant formula from outside U.S. through its Operation Fly Formula Mission.

The FDA also urged infant formula manufacturers worldwide to import products to the U.S., and issued enforcement discretion letters for the importation of the infant formula products from six countries. The FDA flexibilities have resulted in a total estimated quantity of 17 million cans, or about 365 million full-size, 8-ounce bottles of infant formula to date.

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