{
  "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": "Hauppauge",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA040765"
        ],
        "brand_name": [
          "EXTENDED PHENYTOIN SODIUM"
        ],
        "generic_name": [
          "PHENYTOIN SODIUM"
        ],
        "manufacturer_name": [
          "Amneal Pharmaceuticals LLC"
        ],
        "product_ndc": [
          "65162-212"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PHENYTOIN SODIUM"
        ],
        "rxcui": [
          "855671"
        ],
        "spl_id": [
          "2b4f7d43-b5df-46e4-9cb9-216b70a360a0"
        ],
        "spl_set_id": [
          "7e467c02-49a0-4b62-b537-430fdfa4f10e"
        ],
        "package_ndc": [
          "65162-212-03",
          "65162-212-10",
          "65162-212-50",
          "65162-212-11"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0365162212037",
          "0365162212105"
        ],
        "unii": [
          "4182431BJH"
        ]
      },
      "product_type": "Drugs",
      "event_id": "66014",
      "recalling_firm": "Amneal Pharmaceuticals of New York, LLC.",
      "address_1": "85 Adams Avenue",
      "address_2": "N/A",
      "postal_code": "11788",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "IL, NH, NJ, NY, OH, RI, TN",
      "recall_number": "D-66014-001",
      "product_description": "Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141",
      "product_quantity": "895 - 1000 count bottles",
      "reason_for_recall": "Failed dissolution specifications; 18 month CRT",
      "recall_initiation_date": "20130817",
      "center_classification_date": "20131104",
      "termination_date": "20140717",
      "report_date": "20131113",
      "code_info": "Batch/Lot HL50611, exp. 1/2014"
    }
  ]
}