{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Dublin",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA204569"
        ],
        "brand_name": [
          "BELSOMRA"
        ],
        "generic_name": [
          "SUVOREXANT"
        ],
        "manufacturer_name": [
          "Merck Sharp & Dohme LLC"
        ],
        "product_ndc": [
          "0006-0005",
          "0006-0033",
          "0006-0325",
          "0006-0335"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SUVOREXANT"
        ],
        "rxcui": [
          "1547104",
          "1547110",
          "1547112",
          "1547114",
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          "1547118",
          "1547573",
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        "package_ndc": [
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          "0006-0033-10",
          "0006-0033-30",
          "0006-0033-13",
          "0006-0325-10",
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          "0006-0325-13",
          "0006-0335-10",
          "0006-0335-30",
          "0006-0335-13"
        ],
        "is_original_packager": [
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        "nui": [
          "N0000191000",
          "N0000190998",
          "N0000185503",
          "N0000190114"
        ],
        "pharm_class_epc": [
          "Orexin Receptor Antagonist [EPC]"
        ],
        "pharm_class_moa": [
          "Orexin Receptor Antagonists [MoA]",
          "P-Glycoprotein Inhibitors [MoA]",
          "Cytochrome P450 3A Inhibitors [MoA]"
        ],
        "unii": [
          "081L192FO9"
        ]
      },
      "product_type": "Drugs",
      "event_id": "87512",
      "recalling_firm": "Cardinal Health Inc.",
      "address_1": "7000 Cardinal Pl",
      "address_2": "N/A",
      "postal_code": "43017-1091",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "FL, GA, SC",
      "recall_number": "D-0523-2021",
      "product_description": "Belsomra (suvorexant) tablets 20 mg Each tablet contains 20 mg suvorexant.  This package contains 30 Tablets in 3 Blister Cards.  Each Blister Card contains 10 Tablets. Rx only NDC 0006-0335-30 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08880, USA",
      "product_quantity": "299 cartons",
      "reason_for_recall": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
      "recall_initiation_date": "20210315",
      "center_classification_date": "20210524",
      "termination_date": "20240617",
      "report_date": "20210602",
      "code_info": "1778598"
    }
  ]
}