{
  "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": "65092",
      "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-819-2013",
      "product_description": "VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02, b) 380 mg vial in kit NDC 65757-300-01, Rx Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451,",
      "product_quantity": "3,325 vials",
      "reason_for_recall": "Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.",
      "recall_initiation_date": "20121106",
      "center_classification_date": "20130724",
      "termination_date": "20130828",
      "report_date": "20130731",
      "code_info": "Individual vial lot 402-3683AA, EXP 10/13; kit vial lot 2011-003, EXP 08/13",
      "more_code_info": ""
    }
  ]
}