{
  "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": "East Windsor",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA078332"
        ],
        "brand_name": [
          "CARVEDILOL"
        ],
        "generic_name": [
          "CARVEDILOL"
        ],
        "manufacturer_name": [
          "Aurobindo Pharma Limited"
        ],
        "product_ndc": [
          "65862-142",
          "65862-143",
          "65862-144",
          "65862-145"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CARVEDILOL"
        ],
        "rxcui": [
          "200031",
          "200032",
          "200033",
          "686924"
        ],
        "spl_id": [
          "f210723f-29fb-46c7-8ac4-5009d9696d3b"
        ],
        "spl_set_id": [
          "7cc14b86-0833-4c3c-91f3-7963d7052fd5"
        ],
        "package_ndc": [
          "65862-142-01",
          "65862-142-05",
          "65862-142-99",
          "65862-143-01",
          "65862-143-05",
          "65862-143-99",
          "65862-144-01",
          "65862-144-05",
          "65862-144-99",
          "65862-145-01",
          "65862-145-05",
          "65862-145-99"
        ],
        "is_original_packager": [
          true
        ],
        "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": "89045",
      "recalling_firm": "Aurobindo Pharma USA Inc.",
      "address_1": "279 Princeton Hightstown Rd",
      "address_2": "",
      "postal_code": "08520-1401",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the US",
      "recall_number": "D-0263-2022",
      "product_description": "Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Road, East Windsor, NJ, 08520, Made in India, NDC 65862-143-05",
      "product_quantity": "7296 containers",
      "reason_for_recall": "Failed Impurities/Degradation Specifications",
      "recall_initiation_date": "20211115",
      "center_classification_date": "20211201",
      "termination_date": "20230823",
      "report_date": "20211201",
      "code_info": "Batch QG0619030-A, exp 11/2022",
      "more_code_info": ""
    }
  ]
}