{
  "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": "2026-03-18",
    "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": [
          "NDA021879"
        ],
        "brand_name": [
          "NUEDEXTA"
        ],
        "generic_name": [
          "DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE"
        ],
        "manufacturer_name": [
          "Avanir Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "64597-301"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DEXTROMETHORPHAN HYDROBROMIDE",
          "QUINIDINE SULFATE"
        ],
        "rxcui": [
          "1040054",
          "1040058"
        ],
        "spl_id": [
          "545d121c-01b2-4375-9067-52fc8ad23d74"
        ],
        "spl_set_id": [
          "484e0918-3442-49dc-8ccf-177f1f3ee9f3"
        ],
        "package_ndc": [
          "64597-301-13",
          "64597-301-60"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "9D2RTI9KYH",
          "J13S2394HE"
        ]
      },
      "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-0442-2021",
      "product_description": "Nuedexta (dextromethorphan HBr and quinidine sulfate) Capsules 20 mg/10 mg 60 capsules Rx only NDC 64597-301-60 Manufactured by Patheon, Inc. Whitby, ON L1N 5Z5, Canada",
      "product_quantity": "255 bottles",
      "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": "CFBFP"
    }
  ]
}