{
  "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": "Chantilly",
      "state": "VA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA217116"
        ],
        "brand_name": [
          "GABAPENTIN"
        ],
        "generic_name": [
          "GABAPENTIN"
        ],
        "manufacturer_name": [
          "Granules Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "70010-227",
          "70010-228"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "GABAPENTIN"
        ],
        "rxcui": [
          "310433",
          "310434"
        ],
        "spl_id": [
          "3513f676-25fe-02db-e063-6294a90a1f9d"
        ],
        "spl_set_id": [
          "e847bcfa-f3de-404a-8a57-d8a414691e6a"
        ],
        "package_ndc": [
          "70010-227-01",
          "70010-227-05",
          "70010-228-01",
          "70010-228-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0370010228016",
          "0370010227019"
        ],
        "nui": [
          "N0000008486"
        ],
        "pharm_class_pe": [
          "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
        ],
        "unii": [
          "6CW7F3G59X"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95072",
      "recalling_firm": "Granules Pharmaceuticals Inc.",
      "address_1": "3701 Concorde Pkwy",
      "address_2": "",
      "postal_code": "20151-1126",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0634-2024",
      "product_description": "Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA NDC 70010-227-05",
      "product_quantity": "11,808 500-count Bottles",
      "reason_for_recall": "Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets",
      "recall_initiation_date": "20240731",
      "center_classification_date": "20240814",
      "termination_date": "20250612",
      "report_date": "20240814",
      "code_info": "Lot 1380040A, Exp. date July 31, 2025",
      "more_code_info": ""
    }
  ]
}