{
  "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": "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": "80133",
      "recalling_firm": "Jubilant Cadista Pharmaceuticals, Inc.",
      "address_1": "207 Kiley Dr",
      "address_2": "N/A",
      "postal_code": "21801-2249",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "IN, MI, MS, NC, NJ, NY and OH",
      "recall_number": "D-0876-2018",
      "product_description": "Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90",
      "product_quantity": "2,328 bottles (Lot VR417065A) and 2,352 bottles (Lot VR417066A)",
      "reason_for_recall": "Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).",
      "recall_initiation_date": "20180525",
      "center_classification_date": "20180615",
      "termination_date": "20200108",
      "report_date": "20180613",
      "code_info": "Lot #: VR417065A, VR417066A, Exp 10/2019"
    }
  ]
}