{
  "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": "Grand Island",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA017651"
        ],
        "brand_name": [
          "HEPARIN SODIUM"
        ],
        "generic_name": [
          "HEPARIN SODIUM"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "63323-047",
          "63323-542",
          "63323-276",
          "63323-915",
          "63323-543",
          "63323-459",
          "63323-540",
          "63323-262"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "HEPARIN SODIUM"
        ],
        "rxcui": [
          "1361226",
          "1361574",
          "1361615",
          "1362831",
          "1658634",
          "1658647"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
          "d55b4a63-0c04-4874-b74f-9e9b9e8b008c"
        ],
        "package_ndc": [
          "63323-542-01",
          "63323-542-07",
          "63323-276-01",
          "63323-276-02",
          "63323-915-01",
          "63323-047-01",
          "63323-047-10",
          "63323-543-02",
          "63323-459-09",
          "63323-540-01",
          "63323-540-11",
          "63323-540-31",
          "63323-262-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363323276010",
          "0363323047016",
          "0363323543020"
        ],
        "unii": [
          "ZZ45AB24CA"
        ]
      },
      "product_type": "Drugs",
      "event_id": "67330",
      "recalling_firm": "Fresenius Kabi USA, LLC",
      "address_1": "3159 Staley Rd",
      "address_2": "",
      "postal_code": "14072-2028",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1148-2014",
      "product_description": "Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11, 25 vials in tray, each boxed vial individually labeled as: Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11.",
      "product_quantity": "161,650 vials",
      "reason_for_recall": "Subpotent; 18 month time point",
      "recall_initiation_date": "20140122",
      "center_classification_date": "20140305",
      "termination_date": "20160524",
      "report_date": "20140312",
      "code_info": "Lot Number: 6004137, Expiration date: 06/2014",
      "more_code_info": ""
    }
  ]
}