{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Orlando",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA206935"
        ],
        "brand_name": [
          "IRINOTECAN HYDROCHLORIDE"
        ],
        "generic_name": [
          "IRINOTECAN HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Ingenus Pharmaceuticals, LLC"
        ],
        "product_ndc": [
          "50742-401",
          "50742-402"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "IRINOTECAN HYDROCHLORIDE"
        ],
        "rxcui": [
          "1726319",
          "1726324"
        ],
        "spl_id": [
          "3c841594-8a93-4728-b184-0f4bfac73390"
        ],
        "spl_set_id": [
          "d04f2471-3085-4fc8-a657-bb3918d48e6e"
        ],
        "package_ndc": [
          "50742-401-02",
          "50742-402-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0350742401024",
          "0350742402052"
        ],
        "unii": [
          "042LAQ1IIS"
        ]
      },
      "product_type": "Drugs",
      "event_id": "80254",
      "recalling_firm": "Ingenus Pharmaceuticals Llc",
      "address_1": "4190 Millenia Blvd",
      "address_2": "",
      "postal_code": "32839-6408",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0891-2018",
      "product_description": "Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-401-02.",
      "product_quantity": "14089 vials",
      "reason_for_recall": "Superpotent Drug: High out of specification assay value results for potency.",
      "recall_initiation_date": "20180608",
      "center_classification_date": "20180629",
      "termination_date": "20190501",
      "report_date": "20180711",
      "code_info": "Lot #: 17034-2, 17035-2, 17036-2; Exp. 08/19",
      "more_code_info": ""
    }
  ]
}