{
  "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": "Waltham",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA021897"
        ],
        "brand_name": [
          "VIVITROL"
        ],
        "generic_name": [
          "NALTREXONE"
        ],
        "manufacturer_name": [
          "Alkermes, Inc."
        ],
        "product_ndc": [
          "65757-300",
          "65757-301"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "rxcui": [
          "637213",
          "637216"
        ],
        "spl_id": [
          "0f2da087-0d96-4978-9291-4ddf836fb7e5"
        ],
        "spl_set_id": [
          "cd11c435-b0f0-4bb9-ae78-60f101f3703f"
        ],
        "package_ndc": [
          "65757-300-01",
          "65757-302-02",
          "65757-304-03",
          "65757-301-01",
          "65757-303-02",
          "65757-305-03"
        ],
        "is_original_packager": [
          true
        ]
      },
      "product_type": "Drugs",
      "event_id": "67838",
      "recalling_firm": "Alkermes, Inc.",
      "address_1": "852 Winter St",
      "address_2": "N/A",
      "postal_code": "02451-1420",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1556-2014",
      "product_description": "VIVITROL (naltrexone for extended-release injectable suspension);  380 mg vial NDC 65757-300-01; RX Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451.",
      "product_quantity": "4,364 vials",
      "reason_for_recall": "Customer complaints for failure to deliver the dose.",
      "recall_initiation_date": "20140304",
      "center_classification_date": "20140822",
      "termination_date": "20141222",
      "report_date": "20140903",
      "code_info": "Batch Number: 412-3732AA; expiration date 07/2016 (NDC# 65757-302-02; Kit Pacaging Lot Number: 2013-021; expiration date 07/2016 (NDC# 65757-300-01."
    }
  ]
}