{
  "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": "Ongoing",
      "city": "Richmond",
      "state": "VA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "BLA761062"
        ],
        "brand_name": [
          "EVENITY"
        ],
        "generic_name": [
          "ROMOSOZUMAB-AQQG"
        ],
        "manufacturer_name": [
          "Amgen, Inc"
        ],
        "product_ndc": [
          "55513-509",
          "55513-880",
          "55513-998"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "ROMOSOZUMAB"
        ],
        "rxcui": [
          "2123184",
          "2123185",
          "2123190",
          "2123191"
        ],
        "spl_id": [
          "ce745f36-d616-4542-b53a-ad52407d1f8d"
        ],
        "spl_set_id": [
          "471baba2-7154-4488-9891-0db2f46791e7"
        ],
        "package_ndc": [
          "55513-880-01",
          "55513-880-02",
          "55513-998-01",
          "55513-998-02",
          "55513-509-01",
          "55513-509-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "3VHF2ZD92J"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97110",
      "recalling_firm": "Mckesson Medical-Surgical Inc. Corporate Office",
      "address_1": "9954 Maryland Drive",
      "address_2": "Deep Run Iii Ste. 4000",
      "postal_code": "23233",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Within the U.S - OH, VA, FL.",
      "recall_number": "D-0539-2025",
      "product_description": "EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-880-02.",
      "product_quantity": "2 Pre-filled syringes",
      "reason_for_recall": "CGMP Deviations; potential temperature excursions due to transit delays",
      "recall_initiation_date": "20250421",
      "center_classification_date": "20250721",
      "report_date": "20250730",
      "code_info": "Lot: 1178382, Expiration date: 3/31/2027"
    }
  ]
}