{
  "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": "Indianapolis",
      "state": "IN",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "BLA125084"
        ],
        "brand_name": [
          "ERBITUX"
        ],
        "generic_name": [
          "CETUXIMAB"
        ],
        "manufacturer_name": [
          "ImClone LLC"
        ],
        "product_ndc": [
          "66733-948",
          "66733-958"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "CETUXIMAB"
        ],
        "rxcui": [
          "1657658",
          "1657660",
          "1657663",
          "1657664"
        ],
        "spl_id": [
          "f38a33cd-25c7-4d86-8f3c-e3168b6c2b48"
        ],
        "spl_set_id": [
          "8bc6397e-4bd8-4d37-a007-a327e4da34d9"
        ],
        "package_ndc": [
          "66733-948-23",
          "66733-958-23"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175664",
          "N0000020010"
        ],
        "pharm_class_epc": [
          "Epidermal Growth Factor Receptor Antagonist [EPC]"
        ],
        "pharm_class_moa": [
          "HER1 Antagonists [MoA]"
        ],
        "unii": [
          "PQX0D8J21J"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81511",
      "recalling_firm": "Eli Lilly & Co",
      "address_1": "1 Lilly Corporate Ctr",
      "address_2": "",
      "postal_code": "46285-0001",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "AL, AZ, CA, KS, LA, MS, OH, OR, TN, TX and Puerto Rico",
      "recall_number": "D-0248-2019",
      "product_description": "ERBITUX CETUXIMAB Injection, 200 mg/100 mL (2 mg/mL), 100 mL per single-use vial, Rx only, Manufactured by:  ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, Branchburg, NJ 08876 USA.  NDC: 66733-958-23",
      "product_quantity": "9,380 vials",
      "reason_for_recall": "Labeling: Missing label; potential for missing primary container label on the vial.",
      "recall_initiation_date": "20181108",
      "center_classification_date": "20181115",
      "termination_date": "20200422",
      "report_date": "20181121",
      "code_info": "Lot number: C1700167, exp 9/2020",
      "more_code_info": ""
    }
  ]
}