{
  "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": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Rochester",
      "state": "MI",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA091665"
        ],
        "brand_name": [
          "ARGATROBAN"
        ],
        "generic_name": [
          "ARGATROBAN"
        ],
        "manufacturer_name": [
          "Par Health USA, LLC"
        ],
        "product_ndc": [
          "42023-182"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "ARGATROBAN"
        ],
        "rxcui": [
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        ],
        "spl_id": [
          "493ddc78-4566-486f-8cdd-7d6868ddf153"
        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
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        ],
        "is_original_packager": [
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        ],
        "nui": [
          "N0000175980",
          "N0000175518",
          "N0000009963"
        ],
        "pharm_class_epc": [
          "Anti-coagulant [EPC]",
          "Direct Thrombin Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Thrombin Inhibitors [MoA]"
        ],
        "unii": [
          "IY90U61Z3S"
        ]
      },
      "product_type": "Drugs",
      "event_id": "100072",
      "recalling_firm": "Par Health USA, LLC",
      "address_1": "870 Parkdale Rd",
      "address_2": "",
      "postal_code": "48307-1740",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0083-2027",
      "product_description": "Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA 19355/ Argatroban Injection, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Distributed by: Par Pharmaceutical, Cranbury, NJ 08512, NDC 42023-182-89.",
      "product_quantity": "1944 vials",
      "reason_for_recall": "Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.",
      "recall_initiation_date": "20261013",
      "center_classification_date": "20261026",
      "report_date": "20261028",
      "code_info": "Lot #: 84193, Exp Date: 10/2026; 92880, Exp Date: 08/2027.",
      "more_code_info": ""
    }
  ]
}