{
  "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": "Henrico",
      "state": "VA",
      "country": "United States",
      "classification": "Class II",
      "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": "76863",
      "recalling_firm": "Mckesson Medical Surgical",
      "address_1": "9954 Mayland Dr",
      "address_2": "N/A",
      "postal_code": "23233-1464",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0668-2017",
      "product_description": "hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, packaged in 25 Vials per carton, Rx only, APP Fresenius Kabi USA, LLC, Lake Surich, IL  60047, NDC 63323-614-01, Distributed by McKesson Medical-Surgical, Inc.",
      "product_quantity": "98 vials",
      "reason_for_recall": "Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation.",
      "recall_initiation_date": "20170308",
      "center_classification_date": "20170412",
      "termination_date": "20240819",
      "report_date": "20170419",
      "code_info": "Lot #s: 6114311, 6114717, Exp 05/18",
      "more_code_info": ""
    }
  ]
}