{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA090070"
        ],
        "brand_name": [
          "DIVALPROEX SODIUM"
        ],
        "generic_name": [
          "DIVALPROEX SODIUM"
        ],
        "manufacturer_name": [
          "Dr. Reddy's Laboratories Ltd"
        ],
        "product_ndc": [
          "55111-534"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DIVALPROEX SODIUM"
        ],
        "rxcui": [
          "1099569"
        ],
        "spl_id": [
          "0d557d96-7ebb-86b3-bdd1-af0b959bc845"
        ],
        "spl_set_id": [
          "fa823ee0-0c69-6b85-da1e-9bb2e2150ea5"
        ],
        "package_ndc": [
          "55111-534-30",
          "55111-534-60",
          "55111-534-01",
          "55111-534-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0355111534013"
        ],
        "unii": [
          "644VL95AO6"
        ]
      },
      "product_type": "Drugs",
      "event_id": "71374",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1136-2015",
      "product_description": "Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only,  Mfd. By. Dr. Reddy's Laboratories Limited Bachupally 500 090 India --- NDC 55111-534-01",
      "product_quantity": "5,160 bottles",
      "reason_for_recall": "Failed Dissolution Specifications; exceeded specification at the 9 hour time point",
      "recall_initiation_date": "20150522",
      "center_classification_date": "20150612",
      "termination_date": "20170424",
      "report_date": "20150624",
      "code_info": "Lot #C308195, exp 10/2015",
      "more_code_info": ""
    }
  ]
}