{
  "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 III",
      "openfda": {
        "application_number": [
          "ANDA040388"
        ],
        "brand_name": [
          "HYDRALAZINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "HYDRALAZINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "63323-614"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "HYDRALAZINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "966571"
        ],
        "spl_id": [
          "e82473b5-a3ae-4c40-bae5-ff431fc48963"
        ],
        "spl_set_id": [
          "f34904dc-c945-4de4-8594-34e4f4ac1983"
        ],
        "package_ndc": [
          "63323-614-00",
          "63323-614-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363323614003"
        ],
        "unii": [
          "FD171B778Y"
        ]
      },
      "product_type": "Drugs",
      "event_id": "71827",
      "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",
      "recall_number": "D-1327-2015",
      "product_description": "Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Kabi USA 2020 N Ruby Street, Melrose Park, IL 60160-1112 for Fresenius Kabi USA, 3 Corporate Dr Lake Zurich, IL 60047-8930. NDC 63323-614-01",
      "product_quantity": "93,000 vials",
      "reason_for_recall": "Incorrect Expiration Date: The \"11/06\" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)",
      "recall_initiation_date": "20150728",
      "center_classification_date": "20150812",
      "termination_date": "20160308",
      "report_date": "20150819",
      "code_info": "Lot #: 6110593, Exp 11/2016"
    }
  ]
}