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"Executive management should immediately and comprehensively assess your companys global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements," the agency added

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In vitro studies demonstrated cytotoxic activity in HepG2 cells and human liver cells L-02, leading to cell death, and demonstrated in in vivo studies that flavokavain B is responsible for the potentiation of kava hepatotoxicity upon herbdrug interaction in C57BL/6 mice