{
  "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": "Louisville",
      "state": "CO",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA022159"
        ],
        "brand_name": [
          "ORAVERSE"
        ],
        "generic_name": [
          "PHENTOLAMINE MESYLATE"
        ],
        "manufacturer_name": [
          "Septodont, Inc."
        ],
        "product_ndc": [
          "0362-0101"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBMUCOSAL"
        ],
        "substance_name": [
          "PHENTOLAMINE MESYLATE"
        ],
        "rxcui": [
          "1361019",
          "1361021"
        ],
        "spl_id": [
          "f0465990-acce-46dc-9290-344dab1e4f2f"
        ],
        "spl_set_id": [
          "4025cf98-ea87-4531-b0fc-6283c84f63f3"
        ],
        "package_ndc": [
          "0362-0101-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "Y7543E5K9T"
        ]
      },
      "product_type": "Drugs",
      "event_id": "79976",
      "recalling_firm": "Septodont Inc.",
      "address_1": "416 S Taylor Ave",
      "address_2": "N/A",
      "postal_code": "80027-3028",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "USA, Italy and France",
      "recall_number": "D-0828-2018",
      "product_description": "OraVerse (Phentolamine Mesylate) Injection,  0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4mg/1.7mL each, Rx only, Distributed by Septodont, Inc., Louisville, CO 80027, Made in Canada by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0101-10",
      "product_quantity": "8509 boxes",
      "reason_for_recall": "Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS) result that was obtained for related substance (Phentolamide), a known degradation product impurity at the 15 month stability test point.",
      "recall_initiation_date": "20180413",
      "center_classification_date": "20180522",
      "termination_date": "20201214",
      "report_date": "20180516",
      "code_info": "Lot #'s D01894E and D01894G"
    }
  ]
}