{
  "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": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "BLA021148"
        ],
        "brand_name": [
          "NORDITROPIN"
        ],
        "generic_name": [
          "SOMATROPIN"
        ],
        "manufacturer_name": [
          "Novo Nordisk"
        ],
        "product_ndc": [
          "0169-7703",
          "0169-7704",
          "0169-7705",
          "0169-7708"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "SOMATROPIN"
        ],
        "rxcui": [
          "847243",
          "847245",
          "847247",
          "847348",
          "849850",
          "849851",
          "1736262",
          "1736329"
        ],
        "spl_id": [
          "b67c2419-4feb-4ce1-b97e-88760a8e1aee"
        ],
        "spl_set_id": [
          "1058e17c-9261-459c-a3e6-fae38d196c14"
        ],
        "package_ndc": [
          "0169-7704-21",
          "0169-7704-92",
          "0169-7705-21",
          "0169-7705-92",
          "0169-7708-21",
          "0169-7708-92",
          "0169-7703-11",
          "0169-7703-91",
          "0169-7703-21",
          "0169-7703-92"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175606",
          "M0028842"
        ],
        "pharm_class_epc": [
          "Recombinant Human Growth Hormone [EPC]"
        ],
        "pharm_class_cs": [
          "Human Growth Hormone [CS]"
        ],
        "unii": [
          "NQX9KB6PCL"
        ]
      },
      "product_type": "Drugs",
      "event_id": "74044",
      "recalling_firm": "Novo Nordisk Inc",
      "address_1": "1100 Campus Rd",
      "address_2": "N/A",
      "postal_code": "08540-6650",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0956-2016",
      "product_description": "Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen, Rx only,  Novo Nordisk Inc., Plainsboro, NJ --- NDC 0169-7703-21",
      "product_quantity": "723 pens",
      "reason_for_recall": "Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called \"air shot\" step",
      "recall_initiation_date": "20160427",
      "center_classification_date": "20160606",
      "termination_date": "20170502",
      "report_date": "20160615",
      "code_info": "Lot Number FC70222"
    }
  ]
}