{
  "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,
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    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Tarrytown",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "BLA761097"
        ],
        "brand_name": [
          "LIBTAYO"
        ],
        "generic_name": [
          "CEMIPLIMAB-RWLC"
        ],
        "manufacturer_name": [
          "Regeneron Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "61755-008"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "CEMIPLIMAB"
        ],
        "rxcui": [
          "2058830",
          "2058835"
        ],
        "spl_id": [
          "541a4e20-6a70-4164-8504-413f0d654042"
        ],
        "spl_set_id": [
          "4347ae1f-d397-4f18-8b70-03897e1c054a"
        ],
        "package_ndc": [
          "61755-008-01",
          "8494000002"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "6QVL057INT"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99523",
      "recalling_firm": "Regeneron Pharmaceuticals Inc",
      "address_1": "777 Old Saw Mill River Rd",
      "address_2": "",
      "postal_code": "10591-6717",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-0767-2026",
      "product_description": "Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591; Marketed by: Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591),  NDC 61755-008-01",
      "product_quantity": "21,353 vials",
      "reason_for_recall": "Lack of Assurance of Sterility",
      "recall_initiation_date": "20260728",
      "center_classification_date": "20260814",
      "report_date": "20260826",
      "code_info": "Lot: 8494000002, Exp 7/31/28",
      "more_code_info": ""
    }
  ]
}