{
  "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": "South San Francisco",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "BLA103172"
        ],
        "brand_name": [
          "CATHFLO ACTIVASE"
        ],
        "generic_name": [
          "ALTEPLASE"
        ],
        "manufacturer_name": [
          "Genentech, Inc."
        ],
        "product_ndc": [
          "50242-041"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "ALTEPLASE"
        ],
        "spl_id": [
          "0c2938dd-2978-411f-bd76-208fc8754838"
        ],
        "spl_set_id": [
          "91ecdef2-95ff-42dd-a31c-c8a09cab3ad9"
        ],
        "package_ndc": [
          "50242-041-64",
          "50242-041-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "1RXS4UE564"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94653",
      "recalling_firm": "Genentech, Inc.",
      "address_1": "1 Dna Way Bldg 5",
      "address_2": "",
      "postal_code": "94080-4918",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0509-2024",
      "product_description": "Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64",
      "product_quantity": "Lot:3618858 = 105,759; Lot:3618873 =90,359",
      "reason_for_recall": "Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.",
      "recall_initiation_date": "20240520",
      "center_classification_date": "20240524",
      "termination_date": "20250811",
      "report_date": "20240605",
      "code_info": "Lot #: 3618858, 3618873, Exp. Date 01/31/2026",
      "more_code_info": ""
    }
  ]
}