Merck & Co. Inc Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.
Class II · Ongoing
Mar 14, 2021
Cardinal Health Inc. CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).