{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "La Vergne",
      "state": "TN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078251"
        ],
        "brand_name": [
          "CARVEDILOL"
        ],
        "generic_name": [
          "CARVEDILOL"
        ],
        "manufacturer_name": [
          "Major Pharmaceuticals"
        ],
        "product_ndc": [
          "0904-7305",
          "0904-7306",
          "0904-7307",
          "0904-7308"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CARVEDILOL"
        ],
        "rxcui": [
          "200031",
          "200032",
          "200033",
          "686924"
        ],
        "spl_id": [
          "baec14b0-5683-4df3-a46f-6c53af96e9d8"
        ],
        "spl_set_id": [
          "ec6d8d73-9d18-4a9e-ae0c-0ea12059e78e"
        ],
        "package_ndc": [
          "0904-7305-61",
          "0904-7306-61",
          "0904-7307-61",
          "0904-7308-61"
        ],
        "original_packager_product_ndc": [
          "68462-162",
          "68462-163",
          "68462-164",
          "68462-165"
        ],
        "nui": [
          "N0000000099",
          "N0000009923",
          "N0000009924",
          "N0000175553",
          "N0000175556"
        ],
        "pharm_class_moa": [
          "Adrenergic alpha-Antagonists [MoA]",
          "Adrenergic beta1-Antagonists [MoA]",
          "Adrenergic beta2-Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "alpha-Adrenergic Blocker [EPC]",
          "beta-Adrenergic Blocker [EPC]"
        ],
        "unii": [
          "0K47UL67F2"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97449",
      "recalling_firm": "The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories",
      "address_1": "341 Mason Rd",
      "address_2": "N/A",
      "postal_code": "37086-3606",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed nationwide within the United States.",
      "recall_number": "D-0594-2025",
      "product_description": "Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61",
      "product_quantity": "26,628 cartons",
      "reason_for_recall": "CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm",
      "recall_initiation_date": "20250820",
      "center_classification_date": "20250821",
      "report_date": "20250827",
      "code_info": "Lot #: T05693, Exp. Date 03/2026"
    }
  ]
}