{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Pennington",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077614"
        ],
        "brand_name": [
          "CARVEDILOL"
        ],
        "generic_name": [
          "CARVEDILOL"
        ],
        "manufacturer_name": [
          "Zydus Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "68382-092",
          "68382-093",
          "68382-094",
          "68382-095"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CARVEDILOL"
        ],
        "rxcui": [
          "200031",
          "200032",
          "200033",
          "686924"
        ],
        "spl_id": [
          "a7e5dd69-ac10-4f36-a366-4ddc1426aef1"
        ],
        "spl_set_id": [
          "dc6a2d33-aa04-4a04-9cde-901b744d24ca"
        ],
        "package_ndc": [
          "68382-092-17",
          "68382-092-01",
          "68382-092-05",
          "68382-093-17",
          "68382-093-05",
          "68382-093-01",
          "68382-094-17",
          "68382-094-01",
          "68382-094-05",
          "68382-095-17",
          "68382-095-01",
          "68382-095-05"
        ],
        "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": "82714",
      "recalling_firm": "Zydus Pharmaceuticals USA Inc",
      "address_1": "73 Route 31 N",
      "address_2": "N/A",
      "postal_code": "08534-3601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1273-2019",
      "product_description": "Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-093-05",
      "product_quantity": "3900",
      "reason_for_recall": "Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg",
      "recall_initiation_date": "20190425",
      "center_classification_date": "20190507",
      "termination_date": "20210629",
      "report_date": "20190515",
      "code_info": "Z804517, exp Nov 30, 2020"
    }
  ]
}