{
  "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-0088-2022",
      "product_description": "Irbesartan Tablets USP, 300 mg  a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only",
      "product_quantity": "119,544 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#    H804310, exp. date 31/08/2021  H900050, exp. date 30/11/2021  H902262, exp. date 31/05/2022    b) Lot#    H000845, exp. date 28/02/2023  H000846, exp. date 28/02/2023  H000965, exp. date 31/03/2023  H805345, exp. date 30/11/2021  H805346, exp. date 30/11/2021  H805347, exp. date 30/11/2021  H805724, exp. date 30/11/2021  H900061, exp. date 31/12/2021  H900062, exp. date 31/12/2021  H900445, exp. date 31/01/2022  H901489, exp. date 31/03/2022  H901490, exp. date 31/03/2022  H901491, exp. date 31/03/2022  H902261, exp. date 31/05/2022"
    }
  ]
}