United States: Abbott Laboratories will stop sales of its Similac Probiotic Tri-Blend product used for hospitalized preterm infants after the U.S. Food and Drug Administration issued a warning letter, the health regulator said.
In the letter, the FDA said it was concerned that preterm infants were at risk of potentially fatal diseases or infections caused by bacteria or yeast contained in the probiotics.
"The product is an unapproved new drug and an unlicensed biological product being sold in violation" of regulations, the FDA said about Abbott's Similac probiotic product.
An Abbott spokesperson said the issue pertains to Similac Probiotic Tri-Blend, which is used by fewer than 200 hospitals, and that it does not apply to any of the company's infant formula products available at retail stores.
The agency issued a similar warning to California-based Infinant Health in September.
Infinant's product, sold under the brand Evivo with MCT Oil, has since been voluntarily recalled and is no longer available in the country, the FDA said.
Infinant did not immediately respond to a Reuters request for comment.
In 2023, an infant death was reported, and so far more than two dozen other adverse events associated with probiotic products have been reported in the U.S. since 2018, the agency said.
The FDA is also investigating reports that these products may have contributed to additional adverse events, including death, and is working to obtain the evidence and medical records.
Certain probiotic products used in hospital settings to prevent a life-threatening bacterial illness have contributed to invasive diseases, the agency said.
The warning letter is different to the baby formula issue of last year, FDA said, referring to the closure of Abbott's plant in Michigan following a recall of some products due to bacterial contamination.
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