{
  "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": "South San Francisco",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA206192"
        ],
        "brand_name": [
          "COTELLIC"
        ],
        "generic_name": [
          "COBIMETINIB"
        ],
        "manufacturer_name": [
          "Genentech, Inc."
        ],
        "product_ndc": [
          "50242-717"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "COBIMETINIB FUMARATE"
        ],
        "rxcui": [
          "1722370",
          "1722376"
        ],
        "spl_id": [
          "f3881f36-9b41-4c3c-a964-f7a3ecc932d1"
        ],
        "spl_set_id": [
          "c387579e-cee0-4334-bd1e-73f93ac1bde6"
        ],
        "package_ndc": [
          "50242-717-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "6EXI96H8SV"
        ]
      },
      "product_type": "Drugs",
      "event_id": "76726",
      "recalling_firm": "Genentech Inc.",
      "address_1": "1 Dna Way",
      "address_2": "N/A",
      "postal_code": "94080-4990",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "NJ and IL",
      "recall_number": "D-0648-2017",
      "product_description": "Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzerland. Distributed by Genentech USA, Inc., South Francisco, CA. 94080, NDC 50242-717-01,UPC 3 50242-717-01.",
      "product_quantity": "748 bottles",
      "reason_for_recall": "Superpotent Drug: An oversized tablet was found in a bottle.",
      "recall_initiation_date": "20170313",
      "center_classification_date": "20170405",
      "termination_date": "20170512",
      "report_date": "20170412",
      "code_info": "B1009MC, B1009M9, B1009MA; Exp. 02/18  B1009MT 02/19"
    }
  ]
}