{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Eatontown",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA091032"
        ],
        "brand_name": [
          "IRINOTECAN HYDROCHLORIDE"
        ],
        "generic_name": [
          "IRINOTECAN HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Hikma Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "0143-9701",
          "0143-9702"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "IRINOTECAN HYDROCHLORIDE"
        ],
        "rxcui": [
          "1726319",
          "1726324"
        ],
        "spl_id": [
          "204eb37a-642f-4321-9466-414c32a6bbce"
        ],
        "spl_set_id": [
          "be716692-6b4f-47b6-83d1-01665861626b"
        ],
        "package_ndc": [
          "0143-9702-01",
          "0143-9701-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0301439701019"
        ],
        "unii": [
          "042LAQ1IIS"
        ]
      },
      "product_type": "Drugs",
      "event_id": "66447",
      "recalling_firm": "West-Ward Pharmaceutical Corp.",
      "address_1": "465 Industrial Way W",
      "address_2": "N/A",
      "postal_code": "07724-2209",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-66447-001",
      "product_description": "Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial per carton, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Schiffgraben 23, 38690 Vienenburg, Germany; Distributed by: West-Ward Pharmaceutical Corp., Eatontown, NJ  07724 USA, NDC 0143-9702-01.",
      "product_quantity": "9020 vials",
      "reason_for_recall": "Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.",
      "recall_initiation_date": "20130923",
      "center_classification_date": "20131104",
      "termination_date": "20160405",
      "report_date": "20131113",
      "code_info": "Lot #: AC0020, Exp 03/14; AC0023, AC0025, Exp 08/14"
    }
  ]
}