{
  "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": "2026-08-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Pennington",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA209488"
        ],
        "brand_name": [
          "MIRABEGRON"
        ],
        "generic_name": [
          "MIRABEGRON"
        ],
        "manufacturer_name": [
          "Zydus Pharmaceuticals (USA) Inc."
        ],
        "product_ndc": [
          "70710-1159",
          "70710-1160"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MIRABEGRON"
        ],
        "rxcui": [
          "1300791",
          "1300801"
        ],
        "spl_id": [
          "df34c0c9-8528-4fd6-a408-e1d44da0f156"
        ],
        "spl_set_id": [
          "2e40eb74-3b2a-47f7-bf31-fe27484f9bd2"
        ],
        "package_ndc": [
          "70710-1159-3",
          "70710-1159-9",
          "70710-1159-1",
          "70710-1160-3",
          "70710-1160-9",
          "70710-1160-1"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000185008",
          "N0000185007",
          "N0000182137",
          "N0000190114",
          "N0000185503"
        ],
        "pharm_class_epc": [
          "beta3-Adrenergic Agonist [EPC]"
        ],
        "pharm_class_moa": [
          "Adrenergic beta3-Agonists [MoA]",
          "Cytochrome P450 2D6 Inhibitors [MoA]",
          "Cytochrome P450 3A Inhibitors [MoA]",
          "P-Glycoprotein Inhibitors [MoA]"
        ],
        "unii": [
          "MVR3JL3B2V"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99563",
      "recalling_firm": "Zydus Pharmaceuticals (USA) Inc",
      "address_1": "73 Route 31 N",
      "address_2": "",
      "postal_code": "08534-3601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0745-2026",
      "product_description": "Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1159-3.",
      "product_quantity": "",
      "reason_for_recall": "CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.",
      "recall_initiation_date": "20260805",
      "center_classification_date": "20260807",
      "report_date": "20260812",
      "code_info": "Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3",
      "more_code_info": ""
    }
  ]
}