{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Pine Brook",
      "state": "NJ",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA202097"
        ],
        "brand_name": [
          "FENTANYL SYSTEM"
        ],
        "generic_name": [
          "FENTANYL"
        ],
        "manufacturer_name": [
          "ALVOGEN"
        ],
        "product_ndc": [
          "47781-423",
          "47781-424",
          "47781-426",
          "47781-427",
          "47781-428"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TRANSDERMAL"
        ],
        "substance_name": [
          "FENTANYL"
        ],
        "rxcui": [
          "197696",
          "245134",
          "245135",
          "245136",
          "577057"
        ],
        "spl_id": [
          "4b8493ea-0ce4-6949-e063-6294a90a8861"
        ],
        "spl_set_id": [
          "242759ef-cb6d-4e3e-9f8d-5e31efa1f289"
        ],
        "package_ndc": [
          "47781-423-11",
          "47781-423-47",
          "47781-424-11",
          "47781-424-47",
          "47781-426-11",
          "47781-426-47",
          "47781-427-11",
          "47781-427-47",
          "47781-428-11",
          "47781-428-47"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175684",
          "N0000175690"
        ],
        "pharm_class_moa": [
          "Full Opioid Agonists [MoA]"
        ],
        "pharm_class_epc": [
          "Opioid Agonist [EPC]"
        ],
        "unii": [
          "UF599785JZ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "82669",
      "recalling_firm": "Alvogen, Inc",
      "address_1": "10 Bloomfield Ave Bldg B Ste 2",
      "address_2": "N/A",
      "postal_code": "07058-9743",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-1277-2019",
      "product_description": "FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ  07058; Manufactured by: 3M Drug Delivery Systems, St. Paul, MN  55107, NDC 47781-423-47.",
      "product_quantity": "119,608 cartons",
      "reason_for_recall": "Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.",
      "recall_initiation_date": "20190419",
      "center_classification_date": "20190513",
      "termination_date": "20190814",
      "report_date": "20190515",
      "code_info": "Lot#: 180060, Exp 05/2020; 180073, Exp 06/2020."
    }
  ]
}