{
  "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": "Completed",
      "city": "Deerfield",
      "state": "IL",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA022006"
        ],
        "brand_name": [
          "SABRIL"
        ],
        "generic_name": [
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        ],
        "manufacturer_name": [
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        ],
        "product_ndc": [
          "67386-211"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "VIGABATRIN"
        ],
        "rxcui": [
          "250820",
          "860898"
        ],
        "spl_id": [
          "d2901195-e325-4ca5-8453-b020a77ba6aa"
        ],
        "spl_set_id": [
          "a88ac1b4-e2c9-45c0-b321-4785902172e3"
        ],
        "package_ndc": [
          "67386-211-65"
        ],
        "is_original_packager": [
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        ],
        "nui": [
          "N0000175753"
        ],
        "pharm_class_epc": [
          "Anti-epileptic Agent [EPC]"
        ],
        "unii": [
          "GR120KRT6K"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92894",
      "recalling_firm": "Lundbeck LLC",
      "address_1": "6 Parkway North Blvd Ste 400",
      "address_2": "N/A",
      "postal_code": "60015-2522",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the U.S.",
      "recall_number": "D-1142-2023",
      "product_description": "Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65",
      "product_quantity": "10,543 cartons",
      "reason_for_recall": "Cross contamination with other products",
      "recall_initiation_date": "20230817",
      "center_classification_date": "20230829",
      "report_date": "20230906",
      "code_info": "Lot#: 3207333A, 3207334A, Exp 03/2027; 3214707A, 3214709A, 3214710A, Exp 02/2028 ."
    }
  ]
}