{
  "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": "East Brunswick",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA206309"
        ],
        "brand_name": [
          "TEMOZOLOMIDE"
        ],
        "generic_name": [
          "TEMOZOLOMIDE"
        ],
        "manufacturer_name": [
          "Rising Pharma Holdings, Inc."
        ],
        "product_ndc": [
          "16571-816",
          "16571-817",
          "16571-818",
          "16571-819",
          "16571-820",
          "16571-821"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TEMOZOLOMIDE"
        ],
        "rxcui": [
          "313209",
          "313210",
          "313211",
          "317160",
          "700883",
          "700885"
        ],
        "spl_id": [
          "b75f958e-33bc-434d-a4ae-e5fa9d6f4ab5"
        ],
        "spl_set_id": [
          "70996a9d-4a4f-4ed1-ab07-130486aa14ab"
        ],
        "package_ndc": [
          "16571-816-51",
          "16571-816-02",
          "16571-816-41",
          "16571-817-51",
          "16571-817-02",
          "16571-817-41",
          "16571-818-51",
          "16571-818-02",
          "16571-818-41",
          "16571-819-51",
          "16571-819-02",
          "16571-819-41",
          "16571-820-51",
          "16571-820-02",
          "16571-820-41",
          "16571-821-51",
          "16571-821-02"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000000236",
          "N0000175558"
        ],
        "pharm_class_moa": [
          "Alkylating Activity [MoA]"
        ],
        "pharm_class_epc": [
          "Alkylating Drug [EPC]"
        ],
        "unii": [
          "YF1K15M17Y"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98523",
      "recalling_firm": "Rising Pharma Holding, Inc.",
      "address_1": "2 Tower Center Blvd Ste 1401",
      "address_2": "N/A",
      "postal_code": "08816-1149",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the U.S",
      "recall_number": "D-0384-2026",
      "product_description": "Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51.",
      "product_quantity": "1200 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing",
      "recall_initiation_date": "20260303",
      "center_classification_date": "20260304",
      "report_date": "20260311",
      "code_info": "Lot #: 1TM0524003A, Exp. Date 09/2026."
    }
  ]
}