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[9] Visual disturbances have been reported in patients with Leber hereditary optic neuropathy, and rapid B12 administration may precipitate optic nerve atrophy in this genetically predisposed population, mandating extreme caution or alternative therapy

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The FDAs response assessment: corrective actions found deficient The firm submitted two responses to the Form FDA 483 and initiated a voluntary recall of all drug products within expiry that had OOS results

The formula contains Red Clover Flower Extract, a botanical source of isoflavones such as biochanin A, which has been studied in relation to 5-alpha-reductase activity