November 23, 2024

FDA Investigating Another Infant Cronobacter Illness and Death

The FDA is investigating another infant Cronobacter illness and death, according to a news update about the issue of Abbott Nutrition’s Cronobacter contamination problem. The news is contained at the end of the news release.

FDA Investigating Another Infant Cronobacter Illness and Death

The statement says that the FDA has reviewed and investigated a total of 129 complaints associated with Abbott Nutrition powdered infant formula products. Of these, 119 complaints were reported after the voluntary recall of Similac, Electra, and Aliments products on February 17, 2022.

Nine of those complaints were of infant deaths. Only two were associated with the Abbott Nutrition Sturgis, Michigan plant investigation. The FDA states, “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.” Cronobacter was found in environmental samples at the Abbott plant during an FDA inspection, but those samples were not a genetic match to samples taken from two of the infants.

The additional infant Cronobacter illness complaint was received on June 10, 2022 about an infant who died in January 2022. The complaint said that the infant had consumed an Abbott product, but the investigation is in preliminary stages and no further information was provided.

Severe weather recently flooded that Michigan plant and it was closed on Monday June 13, 2022. This will further affect the supply of powdered infant formula in the country. Abbott is “working quickly” to address the damage.

Meanwhile, the FDA is importing more infant formula from manufacturers around the world to help ease the shortage. So far, the equivalent of 365 million full-size 8-ounce bottles has been imported. The FDA states that is it reviewing information about the companies before the product is allowed into the U.S. Parents of infants and children who need specialized metabolic and amino-acid based products have been allowed to purchase Abbott products on a case-by-case basis after consulting with their pediatricians.

 

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