{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Chesterbrook",
      "state": "PA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA021977"
        ],
        "brand_name": [
          "VYVANSE"
        ],
        "generic_name": [
          "LISDEXAMFETAMINE DIMESYLATE"
        ],
        "manufacturer_name": [
          "Takeda Pharmaceuticals America, Inc."
        ],
        "product_ndc": [
          "59417-101",
          "59417-102",
          "59417-103",
          "59417-104",
          "59417-105",
          "59417-106",
          "59417-107",
          "59417-115",
          "59417-116",
          "59417-117",
          "59417-118",
          "59417-119",
          "59417-120"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LISDEXAMFETAMINE DIMESYLATE"
        ],
        "rxcui": [
          "854830",
          "854832",
          "854834",
          "854836",
          "854838",
          "854840",
          "854842",
          "854844",
          "854846",
          "854848",
          "854850",
          "854852",
          "1593856",
          "1593858",
          "1871456",
          "1871459",
          "1871460",
          "1871461",
          "1871462",
          "1871463",
          "1871464",
          "1871465",
          "1871466",
          "1871467",
          "1871468",
          "1871469"
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        "spl_id": [
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        ],
        "spl_set_id": [
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        "package_ndc": [
          "59417-101-10",
          "59417-102-10",
          "59417-103-10",
          "59417-104-10",
          "59417-105-10",
          "59417-106-10",
          "59417-107-10",
          "59417-115-01",
          "59417-116-01",
          "59417-117-01",
          "59417-118-01",
          "59417-119-01",
          "59417-120-01"
        ],
        "is_original_packager": [
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        "unii": [
          "SJT761GEGS"
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      },
      "product_type": "Drugs",
      "event_id": "75170",
      "recalling_firm": "Shire",
      "address_1": "1200 Morris Dr",
      "address_2": "N/A",
      "postal_code": "19087-5507",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0006-2017",
      "product_description": "Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle, Rx Only, Manufactured for: Shire US, Inc., Lexington, MA 02421, NDC 59417-103-10",
      "product_quantity": "7,680 bottles (768,000 capsules)",
      "reason_for_recall": "Presence of Foreign Tablets/Capsules",
      "recall_initiation_date": "20160902",
      "center_classification_date": "20161005",
      "termination_date": "20190308",
      "report_date": "20161012",
      "code_info": "Lot # AF3360B; Exp. 04/19"
    }
  ]
}