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[36] The MMACHC gene product catalyzes the decyanation of cyanocobalamin as well as the dealkylation of alkylcobalamins including methylcobalamin and adenosylcobalamin

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The firm acknowledged that releasing OOS compounded preparations “reflects a deviation from internal quality assurance procedures and obligation to notify patients and prescribers.” But the FDA found that no corrective actions were provided to address the failure to notify patients and prescribers when OOS results were identified