{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Lake Zurich",
      "state": "IL",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA205390"
        ],
        "brand_name": [
          "VECURONIUM BROMIDE"
        ],
        "generic_name": [
          "VECURONIUM BROMIDE"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "63323-781",
          "63323-782"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "VECURONIUM BROMIDE"
        ],
        "rxcui": [
          "859437"
        ],
        "spl_id": [
          "ef0a4c9f-a65e-48dd-b625-eb76a18905f2"
        ],
        "spl_set_id": [
          "d3163bdf-f163-41b5-a38a-3cd6fc1a50ba"
        ],
        "package_ndc": [
          "63323-781-21",
          "63323-781-10",
          "63323-782-23",
          "63323-782-20"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "7E4PHP5N1D"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78949",
      "recalling_firm": "Fresenius Kabi USA, LLC",
      "address_1": "3 Corporate Dr",
      "address_2": "",
      "postal_code": "60047-8930",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide USA",
      "recall_number": "D-0426-2018",
      "product_description": "Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India,  NDC  63323-781-10",
      "product_quantity": "35,620 vials",
      "reason_for_recall": "Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.",
      "recall_initiation_date": "20180116",
      "center_classification_date": "20180215",
      "termination_date": "20190917",
      "report_date": "20180207",
      "code_info": "Lot #:  ZG603, Exp 11/18",
      "more_code_info": ""
    }
  ]
}