{
  "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 III",
      "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": "82682",
      "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 in the USA",
      "recall_number": "D-1242-2019",
      "product_description": "Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; NDC 68382-092-05",
      "product_quantity": "7668 bottles",
      "reason_for_recall": "Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.",
      "recall_initiation_date": "20190422",
      "center_classification_date": "20190425",
      "termination_date": "20210114",
      "report_date": "20190501",
      "code_info": "Lot #: Z803518, Exp 08/2020"
    }
  ]
}