{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Menlo Park",
      "state": "CA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA209310"
        ],
        "brand_name": [
          "SINUVA"
        ],
        "generic_name": [
          "MOMETASONE FUROATE"
        ],
        "manufacturer_name": [
          "Intersect ENT, Inc."
        ],
        "product_ndc": [
          "10599-003"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRASINAL"
        ],
        "substance_name": [
          "MOMETASONE FUROATE"
        ],
        "rxcui": [
          "1995983",
          "1995988"
        ],
        "spl_id": [
          "508796b2-418c-402f-a33f-5766a8d4c18b"
        ],
        "spl_set_id": [
          "e33c1b23-cdc6-4f64-94ba-24b0b42c09bf"
        ],
        "package_ndc": [
          "10599-003-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "04201GDN4R"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91348",
      "recalling_firm": "Intersect ENT, Inc.",
      "address_1": "1555 Adams Dr",
      "address_2": "N/A",
      "postal_code": "94025-1439",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0167-2023",
      "product_description": "SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive, Menlo Park, CA 94025, NDC 10599-003-01.",
      "product_quantity": "9898 pouches",
      "reason_for_recall": "Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.",
      "recall_initiation_date": "20230104",
      "center_classification_date": "20230119",
      "termination_date": "20240821",
      "report_date": "20230125",
      "code_info": "Lot #s: 10111003, Exp 12/31/2022; 10203002, Exp 01/31/2023; 10302002, 10325001, Exp 02/28/2023; 10519001, 10526002, Exp 04/30/2023; 10602002, Exp 05/31/2023; 10819004, Exp 09/30/2023; 21092101, 21111901, Exp 10/31/2023; 21110402, Exp 12/31/2023."
    }
  ]
}