{
  "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": "2026-09-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Lake Zurich",
      "state": "IL",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "BLA761275"
        ],
        "brand_name": [
          "TYENNE"
        ],
        "generic_name": [
          "TOCILIZUMAB-AAZG"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "65219-590",
          "65219-592",
          "65219-594"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "TOCILIZUMAB"
        ],
        "rxcui": [
          "2679431",
          "2679438",
          "2679440",
          "2679441",
          "2679442",
          "2679443"
        ],
        "spl_id": [
          "363d125e-6d69-4bb2-ae09-5eeb5d9edbae"
        ],
        "spl_set_id": [
          "e400bbe6-43c5-4de6-82b9-cb44ce3cd906"
        ],
        "package_ndc": [
          "65219-590-04",
          "65219-592-10",
          "65219-594-20"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000190478",
          "N0000190480"
        ],
        "pharm_class_moa": [
          "Interleukin 6 Receptor Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "Interleukin-6 Receptor Antagonist [EPC]"
        ],
        "unii": [
          "I031V2H011"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99603",
      "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": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0827-2026",
      "product_description": "Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured  by Fresenius Kabi USA, LLC,  Lake Zurich, Illinois, 60047, NDC 65219-594-20.",
      "product_quantity": "4,643 20mL-vials",
      "reason_for_recall": "Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.",
      "recall_initiation_date": "20260810",
      "center_classification_date": "20260901",
      "report_date": "20260902",
      "code_info": "Lot: 16UI07, Exp 08/31/2028"
    }
  ]
}