{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Seymour",
      "state": "IN",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA084903"
        ],
        "brand_name": [
          "PRIMIDONE"
        ],
        "generic_name": [
          "PRIMIDONE"
        ],
        "manufacturer_name": [
          "Lannett Company, Inc."
        ],
        "product_ndc": [
          "0527-1231",
          "0527-1301"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PRIMIDONE"
        ],
        "rxcui": [
          "96304",
          "198150"
        ],
        "spl_id": [
          "99bd0a67-2742-43dd-9ddc-430b9141c3b1"
        ],
        "spl_set_id": [
          "a1a817f7-c190-4825-94eb-442f477187e3"
        ],
        "package_ndc": [
          "0527-1301-01",
          "0527-1301-05",
          "0527-1301-10",
          "0527-1231-01",
          "0527-1231-05",
          "0527-1231-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0305871231011"
        ],
        "nui": [
          "N0000175753",
          "N0000008486"
        ],
        "pharm_class_epc": [
          "Anti-epileptic Agent [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
        ],
        "unii": [
          "13AFD7670Q"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98791",
      "recalling_firm": "Lannett Company Inc.",
      "address_1": "1101 C Ave W",
      "address_2": "",
      "postal_code": "47274-3342",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-0533-2026",
      "product_description": "Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.",
      "product_quantity": "44865 bottles",
      "reason_for_recall": "Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.",
      "recall_initiation_date": "20260424",
      "center_classification_date": "20260518",
      "report_date": "20260527",
      "code_info": "Lot#: 25283038A, Exp 1/31/2028; 25283564A, 25283565A, Exp 3/31/2028; 25285712A Exp 08/31/2028; 25284105A, Exp 4/30/2028; 25284874A, 25284875A, Exp 08/31/2028.",
      "more_code_info": ""
    }
  ]
}