{
  "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"
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        "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": "76001",
      "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-0456-2017",
      "product_description": "MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05",
      "product_quantity": "47, 020 vials",
      "reason_for_recall": "Failed Impurities/Degradation Specifications",
      "recall_initiation_date": "20161216",
      "center_classification_date": "20170202",
      "termination_date": "20180622",
      "report_date": "20170208",
      "code_info": "Lot 6007327, exp. 01-2017; Lot 6007329, exp. 01-2017",
      "more_code_info": ""
    }
  ]
}