{
  "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": "2026-07-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Elizabeth",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA075350"
        ],
        "brand_name": [
          "GABAPENTIN"
        ],
        "generic_name": [
          "GABAPENTIN"
        ],
        "manufacturer_name": [
          "Actavis Pharma, Inc."
        ],
        "product_ndc": [
          "45963-555",
          "45963-556",
          "45963-557"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "GABAPENTIN"
        ],
        "rxcui": [
          "310430",
          "310431",
          "310432"
        ],
        "spl_id": [
          "63f9a25b-d34f-4b4b-8ccd-e0f6dac569f5"
        ],
        "spl_set_id": [
          "5969871e-6c71-4c37-9d63-370718ccc80c"
        ],
        "package_ndc": [
          "45963-555-11",
          "45963-555-50",
          "45963-556-11",
          "45963-556-50",
          "45963-557-11",
          "45963-557-50"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0345963555113",
          "0345963556110"
        ],
        "nui": [
          "N0000008486"
        ],
        "pharm_class_pe": [
          "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
        ],
        "unii": [
          "6CW7F3G59X"
        ]
      },
      "product_type": "Drugs",
      "event_id": "70001",
      "recalling_firm": "Actavis Elizabeth LLC",
      "address_1": "200 Elmora Ave",
      "address_2": "N/A",
      "postal_code": "07202-1106",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Puerto Rico",
      "recall_number": "D-0338-2015",
      "product_description": "Gabapentin Capsules, USP, 100 mg, Rx Only, a) 100 capsules per bottle, NDC 45963-555-11, b) 500 Capsules per bottle, NDC 45963-555-50, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA.",
      "product_quantity": "29,622 Bottles",
      "reason_for_recall": "Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.",
      "recall_initiation_date": "20141215",
      "center_classification_date": "20150108",
      "termination_date": "20151120",
      "report_date": "20150114",
      "code_info": "Lot #s: a) G01966A1, Exp 10/2015, b) G02004A1, Exp 03/2016",
      "more_code_info": ""
    }
  ]
}