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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

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

Regularly check and monitor B12 levels: Routine blood tests can help track your B12 status over time and ensure that any changes are addressed early