{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Zebulon",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA020080"
        ],
        "brand_name": [
          "IMITREX"
        ],
        "generic_name": [
          "SUMATRIPTAN"
        ],
        "manufacturer_name": [
          "GlaxoSmithKline LLC"
        ],
        "product_ndc": [
          "0173-0478",
          "0173-0739",
          "0173-0479"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "SUMATRIPTAN SUCCINATE"
        ],
        "rxcui": [
          "758523",
          "860088",
          "1657160",
          "1657173"
        ],
        "spl_id": [
          "f5834e77-047f-43ab-8b9c-37d3b34afc27"
        ],
        "spl_set_id": [
          "fee7d073-0b99-48f2-7985-0d8cf970894b"
        ],
        "package_ndc": [
          "0173-0739-00",
          "0173-0739-02",
          "0173-0479-00",
          "0173-0478-00"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "J8BDZ68989"
        ]
      },
      "product_type": "Drugs",
      "event_id": "66988",
      "recalling_firm": "GlaxoSmithKline, LLC.",
      "address_1": "1011 North Arendell Ave",
      "address_2": "N/A",
      "postal_code": "27597-1217",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-387-2014",
      "product_description": "Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartridges each containing 6 mg of sumatriptan for subcutaneous injection only, 1 imitrex STATdose Pen, 1 carrying case, Rx only, 6 mg, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in Singapore, NDC 0173-0479-00",
      "product_quantity": "10,469 Systems",
      "reason_for_recall": "Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.",
      "recall_initiation_date": "20131106",
      "center_classification_date": "20131224",
      "termination_date": "20140820",
      "report_date": "20140101",
      "code_info": "Lot#: C636293, Exp: 06/15",
      "more_code_info": ""
    }
  ]
}