{
  "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": "Ongoing",
      "city": "Pulaski",
      "state": "TN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA202910"
        ],
        "brand_name": [
          "IRBESARTAN"
        ],
        "generic_name": [
          "IRBESARTAN"
        ],
        "manufacturer_name": [
          "AvPAK"
        ],
        "product_ndc": [
          "50268-441",
          "50268-440",
          "50268-442"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "IRBESARTAN"
        ],
        "rxcui": [
          "200094",
          "200095",
          "200096"
        ],
        "spl_id": [
          "3c1c8771-3bbc-7b5a-e063-6394a90a192c"
        ],
        "spl_set_id": [
          "61b60f94-35e6-b90b-08ce-fbb2fe011f34"
        ],
        "package_ndc": [
          "50268-440-11",
          "50268-440-15",
          "50268-441-11",
          "50268-441-15",
          "50268-442-11",
          "50268-442-15"
        ],
        "original_packager_product_ndc": [
          "31722-729",
          "31722-730",
          "31722-731"
        ],
        "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": "96172",
      "recalling_firm": "AvKARE",
      "address_1": "615 N 1st St",
      "address_2": "",
      "postal_code": "38478-2403",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0224-2025",
      "product_description": "Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15",
      "product_quantity": "341 cartons",
      "reason_for_recall": "Out of Specification for Dissolution",
      "recall_initiation_date": "20250121",
      "center_classification_date": "20250211",
      "report_date": "20250219",
      "code_info": "Lot 45279, Exp 03/31/2025",
      "more_code_info": ""
    }
  ]
}