{
  "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": "Columbus",
      "state": "OH",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA084903"
        ],
        "brand_name": [
          "PRIMIDONE"
        ],
        "generic_name": [
          "PRIMIDONE"
        ],
        "manufacturer_name": [
          "American Health Packaging"
        ],
        "product_ndc": [
          "68084-202",
          "68084-203"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PRIMIDONE"
        ],
        "rxcui": [
          "96304",
          "198150"
        ],
        "spl_id": [
          "23950268-33a3-8f1e-e063-6394a90a736a"
        ],
        "spl_set_id": [
          "a32e0a00-3ba7-47e7-83c6-a7eac5fbdd11"
        ],
        "package_ndc": [
          "68084-203-11",
          "68084-203-01",
          "68084-202-11",
          "68084-202-01"
        ],
        "original_packager_product_ndc": [
          "0527-1231",
          "0527-1301"
        ],
        "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": "98884",
      "recalling_firm": "Amerisource Health Services LLC",
      "address_1": "2550 John Glenn Ave Ste A",
      "address_2": "",
      "postal_code": "43217-1188",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-0537-2026",
      "product_description": "Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217.   Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11",
      "product_quantity": "225,000 tablets",
      "reason_for_recall": "Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.",
      "recall_initiation_date": "20260501",
      "center_classification_date": "20260518",
      "report_date": "20260527",
      "code_info": "Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027",
      "more_code_info": ""
    }
  ]
}