{
  "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 III",
      "openfda": {
        "application_number": [
          "NDA208143"
        ],
        "brand_name": [
          "TAGITOL V"
        ],
        "generic_name": [
          "BARIUM SULFATE"
        ],
        "manufacturer_name": [
          "E-Z-EM Canada Inc"
        ],
        "product_ndc": [
          "32909-814"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BARIUM SULFATE"
        ],
        "spl_id": [
          "14ae1571-3fcc-425e-aee1-469b5da4d113"
        ],
        "spl_set_id": [
          "30c68756-c7db-bf50-9cd5-ef4b0c7ab1d0"
        ],
        "package_ndc": [
          "32909-814-53",
          "32909-814-55"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000180185",
          "N0000010258"
        ],
        "pharm_class_epc": [
          "Radiographic Contrast Agent [EPC]"
        ],
        "pharm_class_moa": [
          "X-Ray Contrast Activity [MoA]"
        ],
        "unii": [
          "25BB7EKE2E"
        ]
      },
      "product_type": "Drugs",
      "event_id": "66032",
      "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-914-2013",
      "product_description": "Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC 32909-814-53) Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc. Lake Success, NY 11042 Tel: 1-516-333-8230 1-800-544-4624    NDC 32909-814-53",
      "product_quantity": "3,096 bottles",
      "reason_for_recall": "Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.",
      "recall_initiation_date": "20130719",
      "center_classification_date": "20130822",
      "termination_date": "20150129",
      "report_date": "20130828",
      "code_info": "Lot #65846"
    }
  ]
}