{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Plainsboro",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA209637"
        ],
        "brand_name": [
          "OZEMPIC"
        ],
        "generic_name": [
          "SEMAGLUTIDE"
        ],
        "manufacturer_name": [
          "Novo Nordisk Pharmaceutical Industries, LP"
        ],
        "product_ndc": [
          "0169-1302",
          "0169-4136",
          "0169-4132",
          "0169-4130",
          "0169-4772",
          "0169-4181",
          "0169-1305",
          "0169-1310"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "SEMAGLUTIDE"
        ],
        "rxcui": [
          "1991306",
          "1991311",
          "1991316",
          "1991317",
          "2398841",
          "2398842",
          "2599362",
          "2599365",
          "2619152",
          "2619154"
        ],
        "spl_id": [
          "12f15944-a280-494d-9cd1-1e8f93b1077e"
        ],
        "spl_set_id": [
          "adec4fd2-6858-4c99-91d4-531f5f2a2d79"
        ],
        "package_ndc": [
          "0169-4136-11",
          "0169-4136-02",
          "0169-4132-90",
          "0169-4132-97",
          "0169-4132-11",
          "0169-4132-12",
          "0169-4130-01",
          "0169-4130-13",
          "0169-4772-11",
          "0169-4772-12",
          "0169-4772-90",
          "0169-4772-97",
          "0169-4181-03",
          "0169-4181-13",
          "0169-4181-90",
          "0169-4181-97",
          "0169-1302-01",
          "0169-1302-14",
          "0169-1302-90",
          "0169-1302-94",
          "0169-1305-01",
          "0169-1305-14",
          "0169-1310-01",
          "0169-1310-14"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000178480",
          "M0160181",
          "N0000020058"
        ],
        "pharm_class_epc": [
          "GLP-1 Receptor Agonist [EPC]"
        ],
        "pharm_class_cs": [
          "Glucagon-Like Peptide 1 [CS]"
        ],
        "pharm_class_moa": [
          "Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]"
        ],
        "unii": [
          "53AXN4NNHX"
        ]
      },
      "product_type": "Drugs",
      "event_id": "87537",
      "recalling_firm": "Novo Nordisk Inc",
      "address_1": "800 Scudders Mill Rd",
      "address_2": "N/A",
      "postal_code": "08536-1606",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0617-2021",
      "product_description": "OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen, Sample. Not for Resale, Rx only, Novo Nordisk Inc, Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark,  NDC 0169-4132-90 (Pen), NDC 0169-4132-97 (Kit)",
      "product_quantity": "N/A",
      "reason_for_recall": "Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.",
      "recall_initiation_date": "20210322",
      "center_classification_date": "20210610",
      "termination_date": "20221209",
      "report_date": "20210421",
      "code_info": "KP50867, exp 10/31/2022,   KP53021, exp 04/30/2023,   KP52338, exp  02/28/2023,   JP54354, exp 08/31/2022,   KP50676, exp  10/31/2022,   KP51434, exp 11/30/2022,   KP51491, exp  11/30/2022,   KP51781, exp 01/31/2023,  KP52249, exp 01/31/2023,   KP52270, exp  01/31/2023,   KP52722, exp 01/31/2023,   KP52973, exp 01/31/2023,   KP53031, exp  01/31/2023,  KP53221, exp 12.04.2023,   KP53369, exp 01/31/2023"
    }
  ]
}