{
  "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": "Salisbury",
      "state": "MD",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA203536"
        ],
        "brand_name": [
          "VALSARTAN"
        ],
        "generic_name": [
          "VALSARTAN"
        ],
        "manufacturer_name": [
          "Jubilant Cadista Pharmacuticals Inc."
        ],
        "product_ndc": [
          "59746-360",
          "59746-361",
          "59746-362",
          "59746-363"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "VALSARTAN"
        ],
        "rxcui": [
          "349199",
          "349200",
          "349201",
          "349483"
        ],
        "spl_id": [
          "9c828bee-09d3-4021-99e7-e5fd3e83741c"
        ],
        "spl_set_id": [
          "9402b022-5809-4251-dfef-54f6ef5723fe"
        ],
        "package_ndc": [
          "59746-360-30",
          "59746-360-90",
          "59746-360-05",
          "59746-360-03",
          "59746-361-30",
          "59746-361-90",
          "59746-361-05",
          "59746-361-03",
          "59746-362-30",
          "59746-362-90",
          "59746-362-05",
          "59746-362-03",
          "59746-363-30",
          "59746-363-90",
          "59746-363-67",
          "59746-363-32"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0359746363321",
          "0359746363307",
          "0359746361037",
          "0359746362034",
          "0359746360306",
          "0359746360030",
          "0359746361303",
          "0359746362300"
        ],
        "nui": [
          "N0000000070",
          "N0000175561"
        ],
        "pharm_class_moa": [
          "Angiotensin 2 Receptor Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "Angiotensin 2 Receptor Blocker [EPC]"
        ],
        "unii": [
          "80M03YXJ7I"
        ]
      },
      "product_type": "Drugs",
      "event_id": "80836",
      "recalling_firm": "Jubilant Cadista Pharmaceuticals, Inc.",
      "address_1": "207 Kiley Dr",
      "address_2": "",
      "postal_code": "21801-2249",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed throughout the United States to wholesalers and retailers.",
      "recall_number": "D-1106-2018",
      "product_description": "Valsartan Tablets USP, 320 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-363-90",
      "product_quantity": "7,048 bottles",
      "reason_for_recall": "Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.",
      "recall_initiation_date": "20180814",
      "center_classification_date": "20180817",
      "termination_date": "20200108",
      "report_date": "20180829",
      "code_info": "Lot #: VR417062A,  Exp. 09/2019; VR417063A, VR417064A, Exp. 10/2019",
      "more_code_info": ""
    }
  ]
}