{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Hauppauge",
      "state": "NY",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA205101"
        ],
        "brand_name": [
          "GABAPENTIN"
        ],
        "generic_name": [
          "GABAPENTIN"
        ],
        "manufacturer_name": [
          "ScieGen Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "50228-177",
          "50228-178"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "GABAPENTIN"
        ],
        "rxcui": [
          "310433",
          "310434"
        ],
        "spl_id": [
          "176515ec-fdba-417a-b849-86aea6fd7857"
        ],
        "spl_set_id": [
          "5ab9c18b-9568-4dcb-90b0-252aef8f8dc2"
        ],
        "package_ndc": [
          "50228-177-30",
          "50228-177-01",
          "50228-177-05",
          "50228-178-30",
          "50228-178-01",
          "50228-178-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0350228180108",
          "0350228180054",
          "0350228181013",
          "0350228178013",
          "0350228181051",
          "0350228179010",
          "0350228180016",
          "0350228177016",
          "0350228179102",
          "0350228178051",
          "0350228177054"
        ],
        "nui": [
          "N0000008486"
        ],
        "pharm_class_pe": [
          "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
        ],
        "unii": [
          "6CW7F3G59X"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91717",
      "recalling_firm": "Sciegen Pharmaceuticals Inc",
      "address_1": "89 Arkay Dr",
      "address_2": "N/A",
      "postal_code": "11788-3727",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA and Puerto Rico",
      "recall_number": "D-0354-2023",
      "product_description": "Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY 11788, NDC: 50228-177-05.",
      "product_quantity": "4,392 bottles",
      "reason_for_recall": "Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.",
      "recall_initiation_date": "20230217",
      "center_classification_date": "20230227",
      "termination_date": "20240617",
      "report_date": "20230308",
      "code_info": "Lot # G177092, Exp. 11/24",
      "more_code_info": ""
    }
  ]
}