{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Schaumburg",
      "state": "IL",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA207050"
        ],
        "brand_name": [
          "BUSULFAN"
        ],
        "generic_name": [
          "BUSULFAN"
        ],
        "manufacturer_name": [
          "Sagent Pharmaceuticals"
        ],
        "product_ndc": [
          "25021-241"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "BUSULFAN"
        ],
        "rxcui": [
          "253113"
        ],
        "spl_id": [
          "673100ef-2b51-4ba2-af5c-fe7c52220636"
        ],
        "spl_set_id": [
          "086a715e-4958-4bb5-9ebd-86171e6b6203"
        ],
        "package_ndc": [
          "25021-241-10"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000000236",
          "N0000175558"
        ],
        "pharm_class_moa": [
          "Alkylating Activity [MoA]"
        ],
        "pharm_class_epc": [
          "Alkylating Drug [EPC]"
        ],
        "unii": [
          "G1LN9045DK"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98883",
      "recalling_firm": "Sagent Pharmaceuticals",
      "address_1": "1515 E Woodfield Rd Ste 1100",
      "address_2": "",
      "postal_code": "60173-6067",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0539-2026",
      "product_description": "Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.",
      "product_quantity": "Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.",
      "reason_for_recall": "Failed Impurities/Degradation Specifications",
      "recall_initiation_date": "20260504",
      "center_classification_date": "20260518",
      "report_date": "20260527",
      "code_info": "Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.",
      "more_code_info": ""
    }
  ]
}