Probiotics After death of infant, FDA warns hospitals about probiotics for premature babies (Oct 2023) Evivo with MCT Oil, Infinant Health, Bifidobacterium longum subsp. infantis EVC001.

Michael Harrop

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https://www.cnn.com/2023/10/02/health/fda-probiotic-warning/index.html
https://www.fda.gov/media/172606/download

Product info https://web.archive.org/web/20230127121719/https://7157e75ac0509b6a8f5c-5b19c577d01b9ccfe75d2f9e4b17ab55.ssl.cf1.rackcdn.com/JVXOTQRZ-PDF-5-489651-4447750462.pdf

The FDA’s letter points out that the agency has not approved any probiotic product for use in infants. In September, it released a public warning to Infinant Health in which it described Evivo with MCT Oil as “an unapproved new drug and unlicensed biological product.”

The company’s marketing of the probiotic as a drug treatment violated several components of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, the warning says.

Infinant Health said it has agreed to recall Evivo with MCT Oil and notified health care providers and hospitals.
 
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