{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Tokushima",
      "state": "N/A",
      "country": "Japan",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA021436"
        ],
        "brand_name": [
          "ABILIFY"
        ],
        "generic_name": [
          "ARIPIPRAZOLE"
        ],
        "manufacturer_name": [
          "Otsuka America Pharmaceutical, Inc."
        ],
        "product_ndc": [
          "59148-006",
          "59148-007",
          "59148-008",
          "59148-009",
          "59148-010",
          "59148-011"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ARIPIPRAZOLE"
        ],
        "rxcui": [
          "349490",
          "349545",
          "349547",
          "349553",
          "352307",
          "352308",
          "352309",
          "352310",
          "402131",
          "404602",
          "602964",
          "615172"
        ],
        "spl_id": [
          "1b189d15-798d-4bed-a93d-a543ed7abd81"
        ],
        "spl_set_id": [
          "c040bd1d-45b7-49f2-93ea-aed7220b30ac"
        ],
        "package_ndc": [
          "59148-006-13",
          "59148-006-92",
          "59148-007-13",
          "59148-007-35",
          "59148-007-94",
          "59148-008-13",
          "59148-008-35",
          "59148-008-95",
          "59148-009-13",
          "59148-009-35",
          "59148-009-95",
          "59148-010-13",
          "59148-010-35",
          "59148-011-13",
          "59148-011-35"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175430"
        ],
        "pharm_class_epc": [
          "Atypical Antipsychotic [EPC]"
        ],
        "unii": [
          "82VFR53I78"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94382",
      "recalling_firm": "Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.",
      "address_1": "224-18",
      "address_2": "Kawauchi-Cho",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA nationwide.",
      "recall_number": "D-0466-2024",
      "product_description": "Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13",
      "product_quantity": "108,192/30 count bottles or 7 count blister packs",
      "reason_for_recall": "Cross Contamination with Other Products",
      "recall_initiation_date": "20240409",
      "center_classification_date": "20240423",
      "report_date": "20240501",
      "code_info": "Lot # AKS00623A, Exp 01/31/2026; AKS00322A, Exp 02/28/2025",
      "more_code_info": ""
    }
  ]
}