{
  "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": "Gurabo",
      "state": "PR",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA204353"
        ],
        "brand_name": [
          "INVOKAMET"
        ],
        "generic_name": [
          "CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Janssen Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "50458-540",
          "50458-541",
          "50458-542",
          "50458-543",
          "50458-940",
          "50458-941",
          "50458-942",
          "50458-943"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CANAGLIFLOZIN",
          "METFORMIN HYDROCHLORIDE"
        ],
        "rxcui": [
          "1545150",
          "1545156",
          "1545157",
          "1545159",
          "1545161",
          "1545163",
          "1545164",
          "1545166",
          "1810997",
          "1810999",
          "1811002",
          "1811003",
          "1811006",
          "1811007",
          "1811010",
          "1811011"
        ],
        "spl_id": [
          "3ce5755e-f0a3-692b-e063-6294a90a3c1f"
        ],
        "spl_set_id": [
          "6868666b-c25e-40d1-9d1f-306bbe9390c1"
        ],
        "package_ndc": [
          "50458-540-60",
          "50458-540-91",
          "50458-541-60",
          "50458-541-91",
          "50458-542-60",
          "50458-542-91",
          "50458-543-60",
          "50458-543-91",
          "50458-940-01",
          "50458-940-02",
          "50458-941-01",
          "50458-941-02",
          "50458-942-01",
          "50458-942-02",
          "50458-943-01",
          "50458-943-02"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0350458543605",
          "0350458541601"
        ],
        "unii": [
          "786Z46389E",
          "0SAC974Z85"
        ]
      },
      "product_type": "Drugs",
      "event_id": "75449",
      "recalling_firm": "Janssen Ortho L.L.C.",
      "address_1": "Carr # 933 Km 0.1",
      "address_2": "",
      "postal_code": "00778",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-0115-2017",
      "product_description": "Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle, Rx only,  Finished product manufactured by: Janssen Ortho, LLC, Gurabo PR 00778, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, NJ 08560, NDC 50458-543-60",
      "product_quantity": "5346 bottles",
      "reason_for_recall": "Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior of Invokamet bottles in place of the Invokamet prescribing information outsert.",
      "recall_initiation_date": "20161019",
      "center_classification_date": "20161025",
      "termination_date": "20180514",
      "report_date": "20161102",
      "code_info": "Lot #: 16GG581X,  Exp 09/17",
      "more_code_info": ""
    }
  ]
}