{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Salisbury",
      "state": "MD",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA203534"
        ],
        "brand_name": [
          "IRBESARTAN"
        ],
        "generic_name": [
          "IRBESARTAN"
        ],
        "manufacturer_name": [
          "Jubilant Cadista Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "59746-447",
          "59746-448",
          "59746-449"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "IRBESARTAN"
        ],
        "rxcui": [
          "200094",
          "200095",
          "200096"
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        "spl_id": [
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        ],
        "spl_set_id": [
          "068224c4-a34d-32d7-bb2a-7eed44ccf7d3"
        ],
        "package_ndc": [
          "59746-447-30",
          "59746-447-90",
          "59746-447-05",
          "59746-448-30",
          "59746-448-90",
          "59746-448-05",
          "59746-449-30",
          "59746-449-90",
          "59746-449-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0359746447304",
          "0359746448301",
          "0359746449308"
        ],
        "nui": [
          "N0000000070",
          "N0000175561"
        ],
        "pharm_class_moa": [
          "Angiotensin 2 Receptor Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "Angiotensin 2 Receptor Blocker [EPC]"
        ],
        "unii": [
          "J0E2756Z7N"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90610",
      "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": "Nationwide within the United States",
      "recall_number": "D-1293-2022",
      "product_description": "Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-448-90",
      "product_quantity": "9,600 bottles",
      "reason_for_recall": "Failed dissolution specifications.",
      "recall_initiation_date": "20220718",
      "center_classification_date": "20220726",
      "termination_date": "20221122",
      "report_date": "20220803",
      "code_info": "Lot #: IB220023A, exp. date 08/2022",
      "more_code_info": ""
    }
  ]
}