{
  "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": "Maryland Heights",
      "state": "MO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078098"
        ],
        "brand_name": [
          "TECHNETIUM TC 99M SESTAMIBI"
        ],
        "generic_name": [
          "TECHNETIUM TC 99M SESTAMIBI"
        ],
        "manufacturer_name": [
          "Curium US LLC"
        ],
        "product_ndc": [
          "69945-092"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE"
        ],
        "spl_id": [
          "4b00526c-6250-49d7-ba34-459ef89c8f43"
        ],
        "spl_set_id": [
          "4110d0f4-3bcf-4688-a39f-42a81064c796"
        ],
        "package_ndc": [
          "69945-092-20",
          "69945-092-40"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "N6OU7HJ70P"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95839",
      "recalling_firm": "Curium US, LLC",
      "address_1": "2703 Wagner Pl",
      "address_2": "",
      "postal_code": "63043-3421",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide USA and Canada.",
      "recall_number": "D-0164-2025",
      "product_description": "Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetratluoroborate - 1 mg; Stannous Chloride Dihydrate -  0.D75 mg; L-Cysteine Hydrochloride Monohydrate - 1 mg; Sodium Citrate Dihydrate - 2.6 mg; Mannitol - 20 mg.  The pH is adjusted to 5.6 to 5.7 with HCI or NaOH prior to lyophilization. Sealed under nitrogen. 30 Radioassay Information Labels with radiation warning symbol. 1 package insert, Rx only,  Manufacture by: Curium US LLC, Maryland Heights, MO 63043, 69945-092-40",
      "product_quantity": "5,160 vials (172 kits 30 vials/kit)",
      "reason_for_recall": "Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product",
      "recall_initiation_date": "20241126",
      "center_classification_date": "20241226",
      "termination_date": "20251010",
      "report_date": "20250101",
      "code_info": "Lot 092-24006, Catalog # N092D0, Exp 06/15/2026",
      "more_code_info": ""
    }
  ]
}