{
  "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": [
          "ANDA078242"
        ],
        "brand_name": [
          "KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN"
        ],
        "generic_name": [
          "KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "45567-0455"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "MEBROFENIN"
        ],
        "spl_id": [
          "20bf6038-c480-0b7f-e063-6394a90a8d65"
        ],
        "spl_set_id": [
          "11492bd5-2ade-4eb4-a23c-b9be99c0d51a"
        ],
        "package_ndc": [
          "45567-0455-1",
          "45567-0455-2"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "7PV0B6ED98"
        ]
      },
      "product_type": "Drugs",
      "event_id": "79802",
      "recalling_firm": "Pharmalucence, Inc.",
      "address_1": "29 Dunham Rd",
      "address_2": "",
      "postal_code": "01821-5729",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide",
      "recall_number": "D-0815-2018",
      "product_description": "Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC 45567-0455-1 and (30 count), NDC 45567-0455-2 . Manufactured by: Pharmalucence, Inc., Billerica, MA 01821.",
      "product_quantity": "157 units (5 count) and 464 units (30 count)",
      "reason_for_recall": "Failed Stability Specifications",
      "recall_initiation_date": "20180410",
      "center_classification_date": "20180515",
      "termination_date": "20181031",
      "report_date": "20180523",
      "code_info": "Part Number MEM05 and MEB30 both with expiry date 12/2018",
      "more_code_info": ""
    }
  ]
}