{
  "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": "Columbus",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA211623"
        ],
        "brand_name": [
          "CARBAMAZEPINE"
        ],
        "generic_name": [
          "CARBAMAZEPINE"
        ],
        "manufacturer_name": [
          "American Health Packaging"
        ],
        "product_ndc": [
          "60687-583",
          "60687-594"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CARBAMAZEPINE"
        ],
        "rxcui": [
          "402505",
          "402506"
        ],
        "spl_id": [
          "33789d2e-f734-3430-e063-6294a90a71d6"
        ],
        "spl_set_id": [
          "7108d630-89bc-4815-b6fb-a1f4676c496e"
        ],
        "package_ndc": [
          "60687-583-11",
          "60687-583-21",
          "60687-594-11",
          "60687-594-21"
        ],
        "original_packager_product_ndc": [
          "16571-681",
          "16571-682"
        ],
        "nui": [
          "N0000008486",
          "N0000175751",
          "N0000185506",
          "N0000191266",
          "N0000187064",
          "N0000185507",
          "N0000185607"
        ],
        "pharm_class_pe": [
          "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
        ],
        "pharm_class_epc": [
          "Mood Stabilizer [EPC]"
        ],
        "pharm_class_moa": [
          "Cytochrome P450 3A4 Inducers [MoA]",
          "Cytochrome P450 1A2 Inducers [MoA]",
          "Cytochrome P450 2B6 Inducers [MoA]",
          "Cytochrome P450 2C9 Inducers [MoA]",
          "Cytochrome P450 2C19 Inducers [MoA]"
        ],
        "unii": [
          "33CM23913M"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97634",
      "recalling_firm": "Amerisource Health Services LLC",
      "address_1": "2550 John Glenn Ave Ste A",
      "address_2": "N/A",
      "postal_code": "43217-1188",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA.",
      "recall_number": "D-0675-2025",
      "product_description": "Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217.  Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11)",
      "product_quantity": "360 cartons",
      "reason_for_recall": "Failed Dissolution Specifications.",
      "recall_initiation_date": "20250915",
      "center_classification_date": "20250929",
      "report_date": "20251008",
      "code_info": "Lot #: 1024078, Exp. Date 08/31/2026"
    }
  ]
}