New Delhi: Abbott Laboratories will halt sales of its Similac Probiotic Tri-Blend product used for hospitalised preterm infants after receiving a warning letter from the U.S. Food and Drug Administration, as per the health regulator’s statement on Thursday.
The FDA expressed concerns in the letter about the potential risks of fatal diseases or infections caused by bacteria or yeast present in the probiotics for preterm infants.
“The product is selling in violation” of regulations, stated the FDA on Thursday in reference to Abbott’s Similac probiotic product.
An Abbott spokesperson clarified that the issue only applies to Similac Probiotic Tri-Blend, which is used in less than 200 hospitals, and does not affect any of the company’s infant formula products available at retail stores.
In September, the agency issued a similar warning to Infinant Health, based in California.
The FDA informed that Infinant’s product, sold under the brand Evivo with MCT Oil, has been voluntarily recalled and is no longer available in the country.
Infinant did not immediately respond to a Reuters request for comment.
The agency stated that since 2018, in the U.S., an infant death was reported, along with over two dozen other adverse events associated with probiotic products.
The FDA is currently investigating reports that suggest these products may have led to additional adverse events and even death, and is actively seeking the evidence and medical records.
According to the agency, certain probiotic products used in hospital settings for the prevention of life-threatening bacterial illness have contributed to invasive diseases.
The FDA clarified that this warning letter is distinct from last year’s baby formula issue, which resulted in the closure of Abbott’s plant in Michigan due to a recall of some products due to bacterial contamination.
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