{
  "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": "New Albany",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA212593"
        ],
        "brand_name": [
          "VASOPRESSIN"
        ],
        "generic_name": [
          "VASOPRESSIN"
        ],
        "manufacturer_name": [
          "American Regent, Inc."
        ],
        "product_ndc": [
          "0517-1020",
          "0517-1030"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "VASOPRESSIN"
        ],
        "rxcui": [
          "313578",
          "2103182"
        ],
        "spl_id": [
          "36148e09-1c3c-4878-a194-8e10291972ff"
        ],
        "spl_set_id": [
          "0ab267f4-9ec9-44fd-8521-f975074667d9"
        ],
        "package_ndc": [
          "0517-1020-01",
          "0517-1020-25",
          "0517-1030-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0305171030017"
        ],
        "nui": [
          "M0022562",
          "N0000009908",
          "N0000175360"
        ],
        "pharm_class_cs": [
          "Vasopressins [CS]"
        ],
        "pharm_class_pe": [
          "Vasoconstriction [PE]",
          "Decreased Diuresis [PE]"
        ],
        "unii": [
          "Y4907O6MFD"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94619",
      "recalling_firm": "American Regent, Inc.",
      "address_1": "6610 New Albany Rd E",
      "address_2": "",
      "postal_code": "43054-8730",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-0507-2024",
      "product_description": "Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only,  For Intravenous Infusion, American Regent, Inc., Shirley, NY 11967, NDC 0517-1030-01",
      "product_quantity": "2,352 vials",
      "reason_for_recall": "Subpotent product in addition to having out-of-specification results for impurities.",
      "recall_initiation_date": "20240513",
      "center_classification_date": "20240521",
      "termination_date": "20251222",
      "report_date": "20240529",
      "code_info": "Lot #: 23061L1C0, Exp 1/31/2025",
      "more_code_info": ""
    }
  ]
}