{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Indianapolis",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "BLA125469"
        ],
        "brand_name": [
          "TRULICITY"
        ],
        "generic_name": [
          "DULAGLUTIDE"
        ],
        "manufacturer_name": [
          "Eli Lilly and Company"
        ],
        "product_ndc": [
          "0002-3182",
          "0002-1433",
          "0002-1434",
          "0002-2236"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "DULAGLUTIDE"
        ],
        "rxcui": [
          "1551295",
          "1551300",
          "1551304",
          "1551306",
          "2395777",
          "2395779",
          "2395783",
          "2395785"
        ],
        "spl_id": [
          "16dbc870-9954-4989-b370-78bb3520a038"
        ],
        "spl_set_id": [
          "463050bd-2b1c-40f5-b3c3-0a04bb433309"
        ],
        "package_ndc": [
          "0002-1433-01",
          "0002-1433-80",
          "0002-1433-61",
          "0002-1434-01",
          "0002-1434-80",
          "0002-1434-61",
          "0002-2236-01",
          "0002-2236-80",
          "0002-2236-61",
          "0002-3182-01",
          "0002-3182-80",
          "0002-3182-61"
        ],
        "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": [
          "WTT295HSY5"
        ]
      },
      "product_type": "Drugs",
      "event_id": "88505",
      "recalling_firm": "Eli Lilly & Company",
      "address_1": "839 S Delaware St",
      "address_2": "N/A",
      "postal_code": "46225-1782",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-0773-2021",
      "product_description": "Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80",
      "product_quantity": "119,539 4-packs",
      "reason_for_recall": "Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.",
      "recall_initiation_date": "20210819",
      "center_classification_date": "20210826",
      "termination_date": "20230807",
      "report_date": "20210901",
      "code_info": "Lot number: D396436C"
    }
  ]
}