{
  "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": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA077662"
        ],
        "brand_name": [
          "GABAPENTIN"
        ],
        "generic_name": [
          "GABAPENTIN"
        ],
        "manufacturer_name": [
          "Glenmark Pharmaceuticals Inc., USA"
        ],
        "product_ndc": [
          "68462-126",
          "68462-127"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "GABAPENTIN"
        ],
        "rxcui": [
          "310433",
          "310434"
        ],
        "spl_id": [
          "4da1bae0-701b-4b65-a01e-f4bcedfad849"
        ],
        "spl_set_id": [
          "3865a6e3-112c-490c-82ac-35401336b16e"
        ],
        "package_ndc": [
          "68462-126-01",
          "68462-126-05",
          "68462-127-01",
          "68462-127-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368462127018",
          "0368462126011"
        ],
        "nui": [
          "N0000008486"
        ],
        "pharm_class_pe": [
          "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
        ],
        "unii": [
          "6CW7F3G59X"
        ]
      },
      "product_type": "Drugs",
      "event_id": "64995",
      "recalling_firm": "Glenmark Generics Inc., USA",
      "address_1": "750 Corporate Dr",
      "address_2": "",
      "postal_code": "07430-2009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-329-2013",
      "product_description": "Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle   (NDC 68462-126-05), b) 800 mg, 500- count bottle (NDC 68462-127-05), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India, Manufactured for :  Glenmark Generics USA Mahwah, NJ 07430.",
      "product_quantity": "a) 33,138 bottles (500ct) ; b)19,278 bottles (500 ct)",
      "reason_for_recall": "Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature.",
      "recall_initiation_date": "20130405",
      "center_classification_date": "20130516",
      "termination_date": "20141009",
      "report_date": "20130522",
      "code_info": "a) 600mg:     Lot# 02123419, Exp 10/14  Lot# 02123424, Exp 10/14  Lot# 02123430, Exp 10/14  Lot# 02123492,  Exp 10/14  Lot# 02123523, Exp 10/14  Lot# 02123527, Exp 10/14  Lot# 02123532, Exp 10/14  Lot# 02123542, Exp 10/14  Lot# 02123546, Exp 10/14  Lot# 02123551, Exp 10/14  Lot# 02123555, Exp 10/14  Lot# 02123560, Exp 11/14  Lot# 02123566, Exp 11/14  Lot# 02123569, Exp 11/14      b) 800 mg       Lot# 02123440  Exp 10/14  Lot# 02123445  Exp 10/14  Lot# 02123454  Exp 10/14  Lot# 02123465  Exp 10/14  Lot# 02123789  Exp 11/14  Lot# 02123804  Exp 11/14  Lot# 02123821  Exp 11/14  Lot# 02123829  Exp 11/14  Lot# 02123834  Exp 11/14  Lot# 02123841  Exp 11/14  Lot# 02123845  Exp 11/14",
      "more_code_info": ""
    }
  ]
}