{
  "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": "Millburn",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA208547"
        ],
        "brand_name": [
          "NETSPOT"
        ],
        "generic_name": [
          "68GA-DOTATATE"
        ],
        "manufacturer_name": [
          "Advanced Accelerator Applications USA, Inc"
        ],
        "product_ndc": [
          "69488-001"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "spl_id": [
          "9e573457-066c-46b8-9a26-b99ec4e796e6"
        ],
        "spl_set_id": [
          "b2b3be70-17d8-4093-896c-f1c54a2cf242"
        ],
        "package_ndc": [
          "69488-001-40"
        ],
        "is_original_packager": [
          true
        ]
      },
      "product_type": "Drugs",
      "event_id": "89885",
      "recalling_firm": "Advanced Accelerator Applications USA, Inc.",
      "address_1": "57 E Willow St",
      "address_2": "",
      "postal_code": "07041-1416",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA and Puerto Rico",
      "recall_number": "D-0747-2022",
      "product_description": "NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit contains Vial 1 (Reaction vial with lyophilized powder), 1 Single dose vial, consisting of 40 mcg of dotate, 5 mcg of 1,10-phenanthroline, 6 mcg of Gentisic acid, 20 mg of D-Mannitol, and Nitrogen; and Vial 2, 1 Single dose vial of reaction buffer, Rx Only, Manufactured for: Advanced Accelerator Applications USA, Inc., by: Gipharma S.r.l., Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40",
      "product_quantity": "14,089 kits",
      "reason_for_recall": "Subpotent Drug: low out-of-specification results for Vial 1  assay obtained during stability studies.",
      "recall_initiation_date": "20220318",
      "center_classification_date": "20220406",
      "termination_date": "20230104",
      "report_date": "20220413",
      "code_info": "Lot # (Vial 1)/kit: (F03221004 vial) in kit PG1921014, PG1921015, Exp 16-Mar-2022; (F03221005 vial) in kit PG1921016, PG1921017, Exp 18-Mar-2022; (F03221006 vial) in kit PG1921018, PG1921019, Exp 11-May-2022; (F03221007 vial) in kit PG1921020, PG1921021, Exp 04-Aug-2022",
      "more_code_info": ""
    }
  ]
}