FDA Says On October 24, Issued Warning Letter To Abbott Laboratories On Oct. 24, For Product, Similac Probiotic Tri-blend; Has Not Approved Any Probiotic Product For Use As A Drug Or Biological Product In Infants Of Any Age
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The US Food and Drug Administration (FDA) has issued a warning letter to Abbott Laboratories for its product, Similac Probiotic Tri-blend. The FDA states that the product is an unapproved new drug and unlicensed biological product. The product is also adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it contains B. infantis (Bb-02), an unsafe food additive, and S. thermophilus (TH-4®), a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury, when used in preterm infants.
October 26, 2023 | 3:14 pm
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Abbott Laboratories has received a warning from the FDA regarding its Similac Probiotic Tri-blend product. This could potentially lead to legal issues and damage the company's reputation.
The FDA's warning to Abbott Laboratories about its Similac Probiotic Tri-blend product could have negative implications for the company. The product is deemed as an unapproved new drug and unlicensed biological product, which could lead to legal issues. Additionally, the product is considered adulterated under the FD&C Act, which could harm the company's reputation and potentially lead to a decrease in stock price.
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