{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Thousand Oaks",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "BLA125320"
        ],
        "brand_name": [
          "PROLIA"
        ],
        "generic_name": [
          "DENOSUMAB"
        ],
        "manufacturer_name": [
          "Amgen, Inc"
        ],
        "product_ndc": [
          "55513-710"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "DENOSUMAB"
        ],
        "rxcui": [
          "993452",
          "993456"
        ],
        "spl_id": [
          "ccac6498-945e-4b9c-93b3-b3687c1f1ccb"
        ],
        "spl_set_id": [
          "49e5afe9-a0c7-40c4-af9f-f287a80c5c88"
        ],
        "package_ndc": [
          "55513-710-01",
          "55513-710-21"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000187055",
          "N0000187054"
        ],
        "pharm_class_epc": [
          "RANK Ligand Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "RANK Ligand Blocking Activity [MoA]"
        ],
        "unii": [
          "4EQZ6YO2HI"
        ],
        "upc": [
          "355513710015"
        ]
      },
      "product_type": "Drugs",
      "event_id": "66318",
      "recalling_firm": "Amgen, Inc.",
      "address_1": "1 Amgen Center Dr",
      "address_2": "N/A",
      "postal_code": "91320-1730",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico, Canada, Mexico, and clinical distribution in Europe.",
      "recall_number": "D-66318-001",
      "product_description": "Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, Manufactured by: Amgen Manufacturing Ltd., a subsidiary of Amgen Inc., Thousand Oaks, CA  91320-1799,NDC 55513-710-01, UPC 3 55513 71001 5.",
      "product_quantity": "4,163 prefilled syringes",
      "reason_for_recall": "Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.",
      "recall_initiation_date": "20130917",
      "center_classification_date": "20131104",
      "termination_date": "20140602",
      "report_date": "20131113",
      "code_info": "Lot #: 1037592, Exp 07/15"
    }
  ]
}