{
  "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": [
          "ANDA090161"
        ],
        "brand_name": [
          "DIVALPROEX SODIUM"
        ],
        "generic_name": [
          "DIVALPROEX SODIUM"
        ],
        "manufacturer_name": [
          "Dr. Reddy's Laboratories Ltd"
        ],
        "product_ndc": [
          "55111-533"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DIVALPROEX SODIUM"
        ],
        "rxcui": [
          "1099563"
        ],
        "spl_id": [
          "bbff7587-1b4e-6616-e6f5-689bc89e1aea"
        ],
        "spl_set_id": [
          "2e35f833-1cf7-12eb-9567-7a191e32e138"
        ],
        "package_ndc": [
          "55111-533-30",
          "55111-533-60",
          "55111-533-01",
          "55111-533-05",
          "55111-533-79",
          "55111-533-78"
        ],
        "is_original_packager": [
          true
        ],
        "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-1135-2015",
      "product_description": "Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 090 India",
      "product_quantity": "100 count 7479; 500 count - 2544",
      "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": "100 count bottle - Lot #C307859, exp 09/2015;     500 count bottle - Lot #C307859 and Lot# C307812, exp 09/2015",
      "more_code_info": ""
    }
  ]
}