{
  "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": "Ongoing",
      "city": "East Brunswick",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA213212"
        ],
        "brand_name": [
          "CARBIDOPA, LEVODOPA AND ENTACAPONE"
        ],
        "generic_name": [
          "CARBIDOPA, LEVODOPA AND ENTACAPONE"
        ],
        "manufacturer_name": [
          "Rising Pharma Holdings, Inc."
        ],
        "product_ndc": [
          "16571-689",
          "16571-690",
          "16571-691",
          "16571-692",
          "16571-693",
          "16571-694"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CARBIDOPA",
          "LEVODOPA",
          "ENTACAPONE"
        ],
        "rxcui": [
          "403850",
          "403851",
          "403852",
          "730988",
          "810083",
          "810090"
        ],
        "spl_id": [
          "4d1e7e53-059c-4a41-86b0-66d20ce660d0"
        ],
        "spl_set_id": [
          "2f8e82d7-6baf-456a-b8c3-4fda6e317902"
        ],
        "package_ndc": [
          "16571-689-01",
          "16571-690-01",
          "16571-691-01",
          "16571-692-01",
          "16571-693-01",
          "16571-694-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0316571690015",
          "0316571694013",
          "0316571692019",
          "0316571691012",
          "0316571693016"
        ],
        "nui": [
          "N0000175756",
          "N0000175757",
          "N0000193220",
          "M0370111",
          "N0000175754",
          "N0000175755"
        ],
        "pharm_class_moa": [
          "Catechol O-Methyltransferase Inhibitors [MoA]",
          "DOPA Decarboxylase Inhibitors [MoA]"
        ],
        "pharm_class_epc": [
          "Catechol-O-Methyltransferase Inhibitor [EPC]",
          "Aromatic Amino Acid [EPC]",
          "Aromatic Amino Acid Decarboxylation Inhibitor [EPC]"
        ],
        "pharm_class_cs": [
          "Amino Acids, Aromatic [CS]"
        ],
        "unii": [
          "4975G9NM6T",
          "46627O600J",
          "MNX7R8C5VO"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97768",
      "recalling_firm": "Rising Pharma Holding, Inc.",
      "address_1": "2 Tower Center Blvd Ste 1401",
      "address_2": "",
      "postal_code": "08816-1149",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed Nationwide in the USA",
      "recall_number": "D-0029-2026",
      "product_description": "Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ, 08816, Manufactured by Suven Pharmaceuticals Limited, Pashamylaram, Telangana, 205307, India. NDC# 16571-691-01",
      "product_quantity": "2,064 100-count bottles",
      "reason_for_recall": "Product mix up:  complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).",
      "recall_initiation_date": "20251007",
      "center_classification_date": "20251016",
      "report_date": "20251022",
      "code_info": "Lot # CS25070, exp. date 03/31/2027",
      "more_code_info": ""
    }
  ]
}