{
  "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,
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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Alvin",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "BLA017837"
        ],
        "brand_name": [
          "VOLUMEX"
        ],
        "generic_name": [
          "IODINATED I-131 ALBUMIN"
        ],
        "manufacturer_name": [
          "Iso-Tex Diagnostics, Inc."
        ],
        "product_ndc": [
          "50914-7720"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "HUMAN SERUM ALBUMIN I-131"
        ],
        "spl_id": [
          "1f46b3df-897f-4a96-9feb-9e5c9dd2864f"
        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "50914-7720-8"
        ],
        "is_original_packager": [
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        ],
        "unii": [
          "ACH35131L1"
        ]
      },
      "product_type": "Drugs",
      "event_id": "82652",
      "recalling_firm": "Iso-Tex Diagnostics, Inc",
      "address_1": "1511 County Road 129",
      "address_2": "N/A",
      "postal_code": "77511-1466",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "TN",
      "recall_number": "D-1136-2019",
      "product_description": "Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diagnostics, Inc.; NDC 50914-7720-8.",
      "product_quantity": "54 1ml syringes",
      "reason_for_recall": "Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.",
      "recall_initiation_date": "20190415",
      "center_classification_date": "20190418",
      "termination_date": "20201215",
      "report_date": "20190424",
      "code_info": "Lot: V191004-927 Exp. 05/10/19"
    }
  ]
}