{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Durham",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA206551"
        ],
        "brand_name": [
          "BIVALIRUDIN"
        ],
        "generic_name": [
          "BIVALIRUDIN"
        ],
        "manufacturer_name": [
          "Accord Healthcare, Inc."
        ],
        "product_ndc": [
          "16729-275"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "BIVALIRUDIN"
        ],
        "rxcui": [
          "308769"
        ],
        "spl_id": [
          "1fbdba30-8018-d7d3-e063-6294a90ae6b6"
        ],
        "spl_set_id": [
          "c20969cb-72d4-469b-9bd8-332250d896c3"
        ],
        "package_ndc": [
          "16729-275-03",
          "16729-275-67"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0316729275033"
        ],
        "nui": [
          "N0000175980",
          "N0000175518",
          "N0000009963"
        ],
        "pharm_class_epc": [
          "Anti-coagulant [EPC]",
          "Direct Thrombin Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Thrombin Inhibitors [MoA]"
        ],
        "unii": [
          "TN9BEX005G"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92639",
      "recalling_firm": "Accord Healthcare, Inc.",
      "address_1": "1009 Slater Rd Ste 210B",
      "address_2": "N/A",
      "postal_code": "27703-8446",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0918-2023",
      "product_description": "Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-275-67.",
      "product_quantity": "1680 vials",
      "reason_for_recall": "Presence of Particulate Matter: Particulate matter identified as fiber.",
      "recall_initiation_date": "20230703",
      "center_classification_date": "20230713",
      "termination_date": "20241017",
      "report_date": "20230719",
      "code_info": "Lot #: M2212070 Exp. date 08/2024",
      "more_code_info": ""
    }
  ]
}