{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Billerica",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA018124"
        ],
        "brand_name": [
          "KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE"
        ],
        "generic_name": [
          "TC 99M MEDRONATE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "45567-0040"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "TECHNETIUM TC-99M MEDRONATE"
        ],
        "spl_id": [
          "3010d5a9-2402-c30a-e063-6394a90a73ab"
        ],
        "spl_set_id": [
          "703d347c-e240-408a-b69d-9713e958a201"
        ],
        "package_ndc": [
          "45567-0040-1",
          "45567-0040-2"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000177914",
          "N0000000205"
        ],
        "pharm_class_epc": [
          "Radioactive Diagnostic Agent [EPC]"
        ],
        "pharm_class_moa": [
          "Radiopharmaceutical Activity [MoA]"
        ],
        "unii": [
          "X89XV46R07"
        ]
      },
      "product_type": "Drugs",
      "event_id": "80428",
      "recalling_firm": "Pharmalucence, Inc.",
      "address_1": "29 Dunham Rd",
      "address_2": "N/A",
      "postal_code": "01821-5729",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1040-2018",
      "product_description": "Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packaged in a) 5-count box (NDC 45567-0040-1), b) 30-count box, NDC 45567-0040-2 , Rx only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821.",
      "product_quantity": "95 kits",
      "reason_for_recall": "Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.",
      "recall_initiation_date": "20180606",
      "center_classification_date": "20180803",
      "termination_date": "20190311",
      "report_date": "20180815",
      "code_info": "Lot 4223"
    }
  ]
}