{
  "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": "Titusville",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA021346"
        ],
        "brand_name": [
          "RISPERDAL CONSTA"
        ],
        "generic_name": [
          "RISPERIDONE"
        ],
        "manufacturer_name": [
          "Janssen Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "50458-306",
          "50458-309",
          "50458-307",
          "50458-308"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "rxcui": [
          "402010",
          "402011",
          "402012",
          "706822",
          "706825",
          "706827",
          "706829",
          "706831"
        ],
        "spl_id": [
          "42dc490b-4117-142a-e063-6294a90aeb21"
        ],
        "spl_set_id": [
          "bb34ee82-d2c2-43b8-ba21-2825c0954691"
        ],
        "package_ndc": [
          "50458-309-11",
          "50458-309-01",
          "50458-306-11",
          "50458-306-01",
          "50458-307-11",
          "50458-307-01",
          "50458-308-11",
          "50458-308-01"
        ],
        "is_original_packager": [
          true
        ]
      },
      "product_type": "Drugs",
      "event_id": "66261",
      "recalling_firm": "Janssen Pharmaceuticals, Inc.",
      "address_1": "1125 Trenton Harbourton Rd",
      "address_2": "N/A",
      "postal_code": "08560-1503",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1514-2014",
      "product_description": "Risperdal CONSTA  (risperiDONE),  25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560  NDC 50458-306-11",
      "product_quantity": "70,495 kits",
      "reason_for_recall": "Non-Sterility: Janssen  is recalling  one lot of Risperdal CONSTA (risperiDONE)   due to a sterility failure in a  stability sample",
      "recall_initiation_date": "20130911",
      "center_classification_date": "20140805",
      "termination_date": "20150123",
      "report_date": "20140813",
      "code_info": "Vial - 4212AAP1, Kit - 309316, Exp. 07/15"
    }
  ]
}