{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Pennington",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA215037"
        ],
        "brand_name": [
          "NELARABINE"
        ],
        "generic_name": [
          "NELARABINE"
        ],
        "manufacturer_name": [
          "Zydus Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "70710-1726"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "NELARABINE"
        ],
        "rxcui": [
          "603566"
        ],
        "spl_id": [
          "b3627acf-0207-443a-8e5a-0b4ad974715a"
        ],
        "spl_set_id": [
          "e425731e-626b-4141-a997-fb85e077c2a4"
        ],
        "package_ndc": [
          "70710-1726-1",
          "70710-1726-8"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0370710172619"
        ],
        "nui": [
          "N0000000233",
          "N0000175595"
        ],
        "pharm_class_moa": [
          "Nucleic Acid Synthesis Inhibitors [MoA]"
        ],
        "pharm_class_epc": [
          "Nucleoside Metabolic Inhibitor [EPC]"
        ],
        "unii": [
          "60158CV180"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96291",
      "recalling_firm": "Zydus Pharmaceuticals (USA) Inc",
      "address_1": "73 Route 31 N",
      "address_2": "",
      "postal_code": "08534-3601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-0255-2025",
      "product_description": "Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1;  b) 6 x 50 mL Single-Dose Vial, NDC 70710-1726-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ",
      "product_quantity": "36,978 vials",
      "reason_for_recall": "Failed Impurities/Degradation Specifications",
      "recall_initiation_date": "20250213",
      "center_classification_date": "20250306",
      "report_date": "20250312",
      "code_info": "Lot: a) P300072, P300073 Exp. Feb-2025; P300153, Exp. Jun-25; P300195, Exp. Aug-2025; P400014, P400017, Exp. Dec-2025; P400070, Exp. Feb-2026; P400112, May-2026; P400142, Exp. Jul-2026; b) P300068, Exp. Feb-2025; P300154, Exp.Jun-2025; P400015, P400018, Exp. Dec-2025; P400068, Exp. Feb-2026; P400114, Exp. May-2026; P400139, Exp.Jul-2026.",
      "more_code_info": ""
    }
  ]
}