{
  "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": "Ongoing",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA208994"
        ],
        "brand_name": [
          "KIT FOR THE PREPARATION OF TECHNETIUM TC99M MERTIATIDE"
        ],
        "generic_name": [
          "BETIATIDE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "45567-0655"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "BETIATIDE"
        ],
        "spl_id": [
          "21ca1be3-2caf-535c-e063-6394a90a18e5"
        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "45567-0655-1"
        ],
        "is_original_packager": [
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        ],
        "unii": [
          "9NV2SR34P8"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97460",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "N/A",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "D-0658-2025",
      "product_description": "Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC 45567-0655-1",
      "product_quantity": "1870 kits",
      "reason_for_recall": "Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.",
      "recall_initiation_date": "20250903",
      "center_classification_date": "20250922",
      "report_date": "20250924",
      "code_info": "Lot# AD70995; Exp 10/31/2025"
    }
  ]
}