{
  "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": [
          "ANDA075154"
        ],
        "brand_name": [
          "MIDAZOLAM"
        ],
        "generic_name": [
          "MIDAZOLAM HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "63323-411",
          "63323-412"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "MIDAZOLAM HYDROCHLORIDE"
        ],
        "rxcui": [
          "311700",
          "311702"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "63323-411-22",
          "63323-411-27",
          "63323-411-15",
          "63323-411-12",
          "63323-411-18",
          "63323-411-25",
          "63323-411-13",
          "63323-411-10",
          "63323-412-18",
          "63323-412-25",
          "63323-412-03",
          "63323-412-02",
          "63323-412-06",
          "63323-412-05",
          "63323-412-13",
          "63323-412-10"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0363323411183",
          "0363323411138",
          "0363323412135",
          "0363323411220",
          "0363323412180",
          "0363323412036",
          "0363323411152"
        ],
        "unii": [
          "W7TTW573JJ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "63451",
      "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": "U.S. Nationwide Including Puerto Rico",
      "recall_number": "D-0295-2015",
      "product_description": "MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only.  APP Pharmaceuticals, LLC. Schaumburg, IL 60173. NDC: 63323-412-25.",
      "product_quantity": "101,200 Vials",
      "reason_for_recall": "Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.",
      "recall_initiation_date": "20120927",
      "center_classification_date": "20141210",
      "termination_date": "20141212",
      "report_date": "20141217",
      "code_info": "Lot 6003827, Exp. Date 04/2015"
    }
  ]
}