{
  "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": "Central Islip",
      "state": "NY",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA211592"
        ],
        "brand_name": [
          "VIGABATRIN"
        ],
        "generic_name": [
          "VIGABATRIN"
        ],
        "manufacturer_name": [
          "Cipla USA, Inc."
        ],
        "product_ndc": [
          "69097-964"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "VIGABATRIN"
        ],
        "rxcui": [
          "250820"
        ],
        "spl_id": [
          "4cdad60f-7614-47cb-8594-3c0257e55c28"
        ],
        "spl_set_id": [
          "823cc915-0350-4780-85ed-cd1c338e429d"
        ],
        "package_ndc": [
          "69097-964-53"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175753"
        ],
        "pharm_class_epc": [
          "Anti-epileptic Agent [EPC]"
        ],
        "unii": [
          "GR120KRT6K"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93422",
      "recalling_firm": "InvaGen Pharmaceuticals, Inc.",
      "address_1": "550 S Research Pl",
      "address_2": "",
      "postal_code": "11722-4415",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0220-2024",
      "product_description": "Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc., (a subsidiary of Cipla Ltd.), Hauppauge, NY, 11788, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, NDC 69097-964-53",
      "product_quantity": "1240 boxes",
      "reason_for_recall": "Defective Container: powder may leak out of the pouch",
      "recall_initiation_date": "20231117",
      "center_classification_date": "20240108",
      "report_date": "20240117",
      "code_info": "Lot #: NB301030, Exp. Date 03/31/2025",
      "more_code_info": ""
    }
  ]
}