{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Monroe Township",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA021358"
        ],
        "brand_name": [
          "MULTIHANCE"
        ],
        "generic_name": [
          "GADOBENATE DIMEGLUMINE"
        ],
        "manufacturer_name": [
          "BRACCO DIAGNOSTICS INC"
        ],
        "product_ndc": [
          "0270-5264"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "GADOBENATE DIMEGLUMINE"
        ],
        "spl_id": [
          "42adc803-ceea-22aa-459c-f8617b2d8e56"
        ],
        "spl_set_id": [
          "f63abe56-46d9-4e32-afb1-f4e22370717d"
        ],
        "package_ndc": [
          "0270-5264-16",
          "0270-5264-17"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "3Q6PPC19PO"
        ]
      },
      "product_type": "Drugs",
      "event_id": "62735",
      "recalling_firm": "Bracco Diagnostics Inc",
      "address_1": "259 Prospect Plains Rd.",
      "address_2": "Building H",
      "postal_code": "08831",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1665-2012",
      "product_description": "Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct Infusion, For Intravenous Use, Rx only,  a) 50 mL Single Dose Vial, b) 100 mL Single Dose Vial, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Nycomed GmbH, 78224 Singen (Germany), NDC a) 0270-5264-16, b) 0270-5264-17.",
      "product_quantity": "4,870 Vials",
      "reason_for_recall": "Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.",
      "recall_initiation_date": "20120416",
      "center_classification_date": "20120828",
      "termination_date": "20131113",
      "report_date": "20120905",
      "code_info": "Lot #: a) 9J37457, 9J44058, Exp 10/12; b) 9I28973, Exp 09/12"
    }
  ]
}