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FDA Warns of Infant Formula Powders Tied to Infections

Agency is investigating three Cronobacter sakazakii infections and one Salmonella Newport infection among four infants

FRIDAY, Feb. 18, 2022 (HealthDay News) — Several powdered infant formula products have been recalled by Abbott Inc., following reports of four infants developing bacterial infections after consuming the products, the U.S. Food and Drug Administration said Thursday.

“As this is a product used as the sole source of nutrition for many of our nation’s newborns and infants, the FDA is deeply concerned about these reports of bacterial infections,” Frank Yiannas, FDA deputy commissioner for Food Policy and Response, said in an agency news release. “We want to reassure the public that we’re working diligently with our partners to investigate complaints related to these products… while we work to resolve this safety concern as quickly as possible.”

Consumers should not use Similac, Alimentum, or EleCare powdered infant formulas if: the first two digits of the code are 22 through 37; the code on the container contains K8, SH, or Z2; and the expiration date is 4-1-2022 (APR 2022) or later, the FDA warned.

The agency is investigating three Cronobacter sakazakii infections and one Salmonella Newport infection among four infants in three states — Minnesota, Ohio, and Texas. All of the infants were hospitalized, and Cronobacter may have contributed to a death in one case.

The recalled powdered infant formula products were produced at the Abbott Nutrition facility in Sturgis, Michigan, and were sold across the United States and likely exported to other countries, according to the FDA. The agency said it has launched an inspection at the facility. To date, several environmental samples taken at the plant have tested positive for Cronobacter.

A review of Abbott internal records also revealed environmental contamination with Cronobacter and the destruction of product due to the presence of Cronobacter, the FDA said. The FDA is conducting the investigation with the U.S. Centers for Disease Control and Prevention and state and local agencies.

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