{
  "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": "Lake Zurich",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA203182"
        ],
        "brand_name": [
          "CISATRACURIUM"
        ],
        "generic_name": [
          "CISATRACURIUM BESYLATE"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "63323-416",
          "63323-417",
          "63323-418"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "CISATRACURIUM BESYLATE"
        ],
        "rxcui": [
          "199211",
          "199212",
          "1730194"
        ],
        "spl_id": [
          "0431da49-a804-457c-a823-66d8862db3f2"
        ],
        "spl_set_id": [
          "f78a07e2-0d3b-4460-b29e-8c10c90afbda"
        ],
        "package_ndc": [
          "63323-416-01",
          "63323-416-05",
          "63323-417-01",
          "63323-417-10",
          "63323-418-01",
          "63323-418-20"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363323418014",
          "0363323416010",
          "0363323417017"
        ],
        "unii": [
          "80YS8O1MBS"
        ]
      },
      "product_type": "Drugs",
      "event_id": "73751",
      "recalling_firm": "Fresenius Kabi USA, LLC",
      "address_1": "3 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "60047-8930",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-0819-2016",
      "product_description": "Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius Kabi USA, LLC  Lake Zurich, IL 60047, NDC 63323-417-10",
      "product_quantity": "94,560 vials",
      "reason_for_recall": "Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of \u001cPreservative free\u001d on the individual carton label.  The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.",
      "recall_initiation_date": "20160405",
      "center_classification_date": "20160412",
      "termination_date": "20170411",
      "report_date": "20160420",
      "code_info": "Lot #: 6010157, Exp. 01/2017",
      "more_code_info": ""
    }
  ]
}