{
  "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": "Wilson",
      "state": "NC",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA203460"
        ],
        "brand_name": [
          "MIDAZOLAM"
        ],
        "generic_name": [
          "MIDAZOLAM HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "76045-001",
          "76045-211",
          "76045-002",
          "76045-003"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "MIDAZOLAM HYDROCHLORIDE"
        ],
        "rxcui": [
          "998211",
          "1551393",
          "1551395"
        ],
        "spl_id": [
          "ec9c9aee-b95f-4645-bf17-df7f1e3967d3"
        ],
        "spl_set_id": [
          "1cc9ba6e-fa1b-405e-9de8-720c567b2a73"
        ],
        "package_ndc": [
          "76045-211-00",
          "76045-211-20",
          "76045-001-00",
          "76045-001-20",
          "76045-002-00",
          "76045-002-10",
          "76045-003-00",
          "76045-003-20"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "W7TTW573JJ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78396",
      "recalling_firm": "Fresenius Kabi USA, LLC",
      "address_1": "5200 Corporate Pkwy",
      "address_2": "N/A",
      "postal_code": "27893-9412",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0152-2018",
      "product_description": "Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 76045-001-20",
      "product_quantity": "203136 syringes",
      "reason_for_recall": "Labeling: Label MIX-UP.  Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL",
      "recall_initiation_date": "20171027",
      "center_classification_date": "20180104",
      "termination_date": "20201005",
      "report_date": "20180110",
      "code_info": "Lot: 6400048"
    }
  ]
}