{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Melrose Park",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078052"
        ],
        "brand_name": [
          "FOSPHENYTOIN"
        ],
        "generic_name": [
          "FOSPHENYTOIN SODIUM"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "63323-403"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "FOSPHENYTOIN SODIUM"
        ],
        "rxcui": [
          "1670195",
          "1670200"
        ],
        "spl_id": [
          "84385df0-4793-47d2-8e49-5c84668a0ba3"
        ],
        "spl_set_id": [
          "b60c9c82-e5c7-4e05-98c7-5bbba4af04b2"
        ],
        "package_ndc": [
          "63323-403-01",
          "63323-403-02",
          "63323-403-04",
          "63323-403-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363323403010",
          "0363323403041"
        ],
        "unii": [
          "7VLR55452Z"
        ]
      },
      "product_type": "Drugs",
      "event_id": "68152",
      "recalling_firm": "Fresenius Kabi USA, LLC",
      "address_1": "2045 Cornell Ave",
      "address_2": "",
      "postal_code": "60160-1002",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-1429-2014",
      "product_description": "Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-10",
      "product_quantity": "728,880 vials",
      "reason_for_recall": "Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.",
      "recall_initiation_date": "20140502",
      "center_classification_date": "20140709",
      "termination_date": "20160524",
      "report_date": "20140716",
      "code_info": "Lot #  6003854; 04/14  6003855; 04/14  6004011; 05/14  6003961; 05/14  6004091; 06/14  6004092; 06/14  6004553; 08/14  6004554; 08/14  6004588; 09/14  6004589; 09/14  6005201; 12/14  6005202; 12/14  6005293; 12/14  6005294; 12/14  6005545; 02/15  6005546; 02/15  6005831; 03/15  6005832; 03/15  6005973; 04/15  6005974; 04/15  6006035; 05/15  6006036; 05/15  6006037; 05/15  6006174; 05/15  6006175; 05/15  6006176; 06/15  6006449; 07/15  6006450; 07/15  6006451; 07/15  6007168; 11/15",
      "more_code_info": ""
    }
  ]
}