{
  "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-0086-2022",
      "product_description": "Irbesartan Tablets USP, 75 mg  a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only",
      "product_quantity": "51,144 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#    H000843, exp. date 28/02/2023  H805727, exp. date 30/11/2021  H901579, exp. date 31/03/2022    b) Lot#    H000844, exp. date 28/02/2023  H000964, exp. date 31/03/2023  H804311, exp. date 31/08/2021  H805267, exp. date 30/11/2021  H805268, exp. date 30/11/2021  H805269, exp. date 30/11/2021  H805725, exp. date 30/11/2021  H805726, exp. date 30/11/2021  H901497, exp. date 31/01/2022  H901577, exp. date 31/03/2022  H901578, exp. date 31/03/2022  H902258, exp. date 31/05/2022"
    }
  ]
}