{
  "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": "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": "82085",
      "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": "U.S.A. Nationwide",
      "recall_number": "D-0507-2019",
      "product_description": "Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India  NDC 55111-533-01",
      "product_quantity": "10,656 bottles",
      "reason_for_recall": "Failed Dissolution Specifications: Out of specification results observed for high dissolution.",
      "recall_initiation_date": "20190131",
      "center_classification_date": "20190215",
      "termination_date": "20230214",
      "report_date": "20190227",
      "code_info": "Lot #: C802676, Exp 03/20",
      "more_code_info": ""
    }
  ]
}