{
  "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": "Terminated",
      "city": "Greenville",
      "state": "SC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA040253"
        ],
        "brand_name": [
          "ETHOSUXIMIDE"
        ],
        "generic_name": [
          "ETHOSUXIMIDE"
        ],
        "manufacturer_name": [
          "PAI Holdings, LLC dba PAI Pharma"
        ],
        "product_ndc": [
          "0121-0670"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ETHOSUXIMIDE"
        ],
        "rxcui": [
          "251322"
        ],
        "spl_id": [
          "14d8b71e-abd8-49d4-b4cc-82880e54db8c"
        ],
        "spl_set_id": [
          "8a5cc930-0b36-48a8-9ad0-de633b208742"
        ],
        "package_ndc": [
          "0121-0670-16"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0301210670169"
        ],
        "nui": [
          "N0000175753",
          "N0000008486"
        ],
        "pharm_class_epc": [
          "Anti-epileptic Agent [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
        ],
        "unii": [
          "5SEH9X1D1D"
        ]
      },
      "product_type": "Drugs",
      "event_id": "88392",
      "recalling_firm": "PAI Holdings, LLC. dba Pharmaceutical Associates Inc",
      "address_1": "1700 Perimeter Rd",
      "address_2": "N/A",
      "postal_code": "29605-5252",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed Nationwide in the USA",
      "recall_number": "D-0723-2021",
      "product_description": "Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY,  Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0670-16",
      "product_quantity": "75 cases (6 bottles/case)",
      "reason_for_recall": "Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.",
      "recall_initiation_date": "20210729",
      "center_classification_date": "20210812",
      "termination_date": "20221202",
      "report_date": "20210818",
      "code_info": "Lot: C9BC Exp. 31OCT2022"
    }
  ]
}