{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Livonia",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA090161"
        ],
        "brand_name": [
          "DIVALPROEX SODIUM"
        ],
        "generic_name": [
          "DIVALPROEX SODIUM"
        ],
        "manufacturer_name": [
          "Major Pharmaceuticals"
        ],
        "product_ndc": [
          "0904-6363"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DIVALPROEX SODIUM"
        ],
        "rxcui": [
          "1099563"
        ],
        "spl_id": [
          "7b77fe8c-7100-4756-90ce-0dba2543d9e4"
        ],
        "spl_set_id": [
          "4ef6c5fd-42b2-4419-9b5a-e6d63571e3a0"
        ],
        "package_ndc": [
          "0904-6363-45",
          "0904-6363-61"
        ],
        "original_packager_product_ndc": [
          "55111-533"
        ],
        "unii": [
          "644VL95AO6"
        ]
      },
      "product_type": "Drugs",
      "event_id": "83460",
      "recalling_firm": "MAJOR PHARMACEUTICALS",
      "address_1": "17177 N Laurel Park Dr",
      "address_2": "N/A",
      "postal_code": "48152-2693",
      "voluntary_mandated": "N/A",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-1583-2019",
      "product_description": "DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61.",
      "product_quantity": "828 100-count unit dose cartons",
      "reason_for_recall": "cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.",
      "recall_initiation_date": "20190424",
      "center_classification_date": "20190801",
      "termination_date": "20200716",
      "report_date": "20190807",
      "code_info": "Lot# M02250 EXP 10/2020."
    }
  ]
}