{
  "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": "Alpharetta",
      "state": "GA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA040573"
        ],
        "brand_name": [
          "PHENYTOIN SODIUM"
        ],
        "generic_name": [
          "PHENYTOIN SODIUM"
        ],
        "manufacturer_name": [
          "Acella Pharmaceuticals, LLC"
        ],
        "product_ndc": [
          "42192-614"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "PHENYTOIN SODIUM"
        ],
        "rxcui": [
          "1670351",
          "1670353"
        ],
        "spl_id": [
          "ae14cce7-f65a-45e0-8ff4-9388d0a806d2"
        ],
        "spl_set_id": [
          "6922f32f-8bed-4c09-8103-27987bcbd104"
        ],
        "package_ndc": [
          "42192-614-10",
          "42192-614-30",
          "42192-614-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "4182431BJH"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91149",
      "recalling_firm": "Acella Pharmaceuticals, LLC",
      "address_1": "1880 Mcfarland Pkwy Ste 110",
      "address_2": "N/A",
      "postal_code": "30005-1795",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA.",
      "recall_number": "D-0069-2023",
      "product_description": "Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, NDC 42192-614-10, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005",
      "product_quantity": "574 cartons",
      "reason_for_recall": "Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.",
      "recall_initiation_date": "20221114",
      "center_classification_date": "20221123",
      "termination_date": "20240821",
      "report_date": "20221130",
      "code_info": "Lot: E025A001 Exp. 07/2023"
    }
  ]
}