{
  "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": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA077715"
        ],
        "brand_name": [
          "BUPROPION HYDROCHLORIDE"
        ],
        "generic_name": [
          "BUPROPION HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Actavis Pharma, Inc."
        ],
        "product_ndc": [
          "0591-3331"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BUPROPION HYDROCHLORIDE"
        ],
        "rxcui": [
          "993541"
        ],
        "spl_id": [
          "08ef0752-1fcf-418b-9b72-3fbab8b23058"
        ],
        "spl_set_id": [
          "a1e768fd-c28f-4b49-822d-ccc315b4099c"
        ],
        "package_ndc": [
          "0591-3331-30",
          "0591-3331-19",
          "0591-3331-05"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "ZG7E5POY8O"
        ]
      },
      "product_type": "Drugs",
      "event_id": "66961",
      "recalling_firm": "Actavis Inc",
      "address_1": "400 Interpace Pkwy",
      "address_2": "",
      "postal_code": "07054-1120",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-1043-2014",
      "product_description": "BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05),  Manufactactred By: Watson Laboratories, Inc. Corona, CA 92880",
      "product_quantity": "139,944 bottles",
      "reason_for_recall": "Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.",
      "recall_initiation_date": "20131115",
      "center_classification_date": "20140129",
      "termination_date": "20150616",
      "report_date": "20140205",
      "code_info": "Lots: 524099M, 524100A, 521687A",
      "more_code_info": ""
    }
  ]
}