{
  "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": "Kirkland",
      "state": "",
      "country": "Canada",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "BLA017881"
        ],
        "brand_name": [
          "DRAXIMAGE MAA"
        ],
        "generic_name": [
          "KIT FOR THE PREPARATION OF TECHNETIUM TC 99M ALBUMIN AGGREGATED"
        ],
        "manufacturer_name": [
          "Jubilant DraxImage Inc"
        ],
        "product_ndc": [
          "65174-270"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "ALBUMIN AGGREGATED"
        ],
        "spl_id": [
          "889b7899-9b87-47c2-bb8b-dc896b305186"
        ],
        "spl_set_id": [
          "bbefaa05-1dc0-3ae7-7264-ce1eddf0da2b"
        ],
        "package_ndc": [
          "65174-270-30"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "799C8VF17R"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90455",
      "recalling_firm": "Jubilant Draximage Inc",
      "address_1": "16751 Rte Transcanadienne",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed to retailers nationwide.",
      "recall_number": "D-1189-2022",
      "product_description": "Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg per vial, 30 glass vials per carton, Rx Only, Manufactured for Jubilant Draximage Inc. Kirkland, Canada, NDC 65174-270-30.",
      "product_quantity": "519 cartons/30 vials each",
      "reason_for_recall": "Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.",
      "recall_initiation_date": "20220616",
      "center_classification_date": "20220708",
      "termination_date": "20230725",
      "report_date": "20220720",
      "code_info": "Lot # 1H005, exp. date Nov 30, 2023",
      "more_code_info": ""
    }
  ]
}