Kingsway Trading Inc. of Brooklyn, NY is recalling its 1.06 oz (30g) bottles of “Well Balance Xanthium & Siler Combo (Bi Yan Pian)” Batch No. 130401 & Batch No. 150201 because they contain the presence of undeclared Ephedra Herba (ma huang), an FDA banned item. Dietary supplements containing ephedrine alkaloids pose a risk of serious adverse events, including heart attack, stroke, and death, and that these risks are unreasonable in light of any benefits that may result from the use of these products under their labeled conditions of use, or under ordinary conditions of use if the labeling is silent.
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The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.
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