{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Baltimore",
      "state": "MD",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA201531"
        ],
        "brand_name": [
          "IRBESARTAN"
        ],
        "generic_name": [
          "IRBESARTAN"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "68180-411",
          "68180-410",
          "68180-412"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "IRBESARTAN"
        ],
        "rxcui": [
          "200094",
          "200095",
          "200096"
        ],
        "spl_id": [
          "22c8bdba-6c34-485a-af89-3aafd7fd8605"
        ],
        "spl_set_id": [
          "a7c093c2-3eef-4956-8a14-c36aada0304f"
        ],
        "package_ndc": [
          "68180-410-06",
          "68180-410-09",
          "68180-411-02",
          "68180-411-06",
          "68180-411-09",
          "68180-412-02",
          "68180-412-06",
          "68180-412-09"
        ],
        "is_original_packager": [
          true
        ],
        "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": "88856",
      "recalling_firm": "Lupin Pharmaceuticals Inc.",
      "address_1": "Harborplace Tower",
      "address_2": "111 S Calvert St Fl 21st",
      "postal_code": "21202-6174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed to major distributors who may have further distributed the product nationwide.",
      "recall_number": "D-0087-2022",
      "product_description": "Irbesartan Tablets USP, 150 mg  a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only",
      "product_quantity": "134,016 bottles",
      "reason_for_recall": "CGMP Deviations: impurity N-nitrosoirbesartan detected in API",
      "recall_initiation_date": "20211012",
      "center_classification_date": "20211101",
      "termination_date": "20230130",
      "report_date": "20211110",
      "code_info": "a) Lot#    H804403, exp. date 31/08/2021  H805251, exp. date 30/11/2021  H805640, exp. date 30/11/2021  H901580; exp. date 30/04/2022    b) Lot#    H804492, exp. date 31/08/2021  H805252, exp. date 30/11/2021  H805253, exp. date30/11/2021  H805641, exp. date30/11/2021  H805642, exp. date30/11/2021  H805643, exp. date 30/11/2021  H901581, exp. date 30/04/2021  H902139, exp. date 30/04/2022  H902140, exp. date 30/04/2022"
    }
  ]
}