{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Cranbury",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078536"
        ],
        "brand_name": [
          "CARBIDOPA AND LEVODOPA"
        ],
        "generic_name": [
          "CARBIDOPA AND LEVODOPA"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "62756-517",
          "62756-518",
          "62756-519",
          "62756-985"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CARBIDOPA",
          "LEVODOPA"
        ],
        "rxcui": [
          "197443",
          "197444",
          "197445"
        ],
        "spl_id": [
          "d77ed25a-588d-4d22-855f-f93ba5b4003c"
        ],
        "spl_set_id": [
          "829c35f9-ace0-11dd-8800-f3e252b43544"
        ],
        "package_ndc": [
          "62756-517-83",
          "62756-517-88",
          "62756-517-08",
          "62756-517-13",
          "62756-517-18",
          "62756-518-83",
          "62756-518-88",
          "62756-518-08",
          "62756-518-13",
          "62756-518-18",
          "62756-519-83",
          "62756-519-88",
          "62756-519-08",
          "62756-519-13",
          "62756-519-18",
          "62756-985-01",
          "62756-985-02"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0362756517882",
          "0362756519886",
          "0362756518889"
        ],
        "nui": [
          "N0000193220",
          "M0370111",
          "N0000175754",
          "N0000175755"
        ],
        "pharm_class_epc": [
          "Aromatic Amino Acid [EPC]",
          "Aromatic Amino Acid Decarboxylation Inhibitor [EPC]"
        ],
        "pharm_class_cs": [
          "Amino Acids, Aromatic [CS]"
        ],
        "pharm_class_moa": [
          "DOPA Decarboxylase Inhibitors [MoA]"
        ],
        "unii": [
          "46627O600J",
          "MNX7R8C5VO"
        ]
      },
      "product_type": "Drugs",
      "event_id": "76230",
      "recalling_firm": "Sun Pharmaceutical Industries, Inc.",
      "address_1": "270 Prospect Plains Rd",
      "address_2": "N/A",
      "postal_code": "08512-3605",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0455-2017",
      "product_description": "Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg a) 100-count bottles (NDC 62756-519-88), b) 500-count bottles (NDC 62756-519-13) Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd.  Halol-Baroda Highway, Halol-389 350 Gujarat, India.",
      "product_quantity": "8,537 bottles",
      "reason_for_recall": "Failed Dissolution Specifications",
      "recall_initiation_date": "20170112",
      "center_classification_date": "20170202",
      "termination_date": "20180629",
      "report_date": "20170208",
      "code_info": "a) JKP5530A Exp. 12/17, JKP3991A   Exp. 11/17,  JKR6535A  Exp. 07/18  b) JKP5529A  Exp. 11/17",
      "more_code_info": ""
    }
  ]
}