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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

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Inhibition of Methyldigoxin-Induced Arrhythmias by Pentadecapeptide BPC 157: A Relation With NO-System