{
  "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": "Sharm",
      "state": "",
      "country": "United Arab Emirates",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA078866"
        ],
        "brand_name": [
          "BUPROPION HYDROCHLORIDE"
        ],
        "generic_name": [
          "BUPROPION HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "47335-736",
          "47335-737",
          "47335-738"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BUPROPION HYDROCHLORIDE"
        ],
        "rxcui": [
          "993503",
          "993518",
          "993536"
        ],
        "spl_id": [
          "b8e6ae63-c5d7-4481-b7b0-17e135670515"
        ],
        "spl_set_id": [
          "29848192-7de3-4c0d-a822-1268dcf128b0"
        ],
        "package_ndc": [
          "47335-736-86",
          "47335-736-88",
          "47335-736-08",
          "47335-736-13",
          "47335-737-86",
          "47335-737-88",
          "47335-737-08",
          "47335-737-13",
          "47335-738-86",
          "47335-738-88",
          "47335-738-08",
          "47335-738-13"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0347335738865",
          "0347335737868"
        ],
        "unii": [
          "ZG7E5POY8O"
        ]
      },
      "product_type": "Drugs",
      "event_id": "71949",
      "recalling_firm": "Sun Pharma Global Fze",
      "address_1": "Office # 43 Block Y Saif Zone",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-1345-2015",
      "product_description": "buPROPion Hydrochloride Extended-¿release Tablets USP  (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, Manufactured By: Sun Pharmaceutical Ind. Ltd., Halol Baroda Highway, Halol 389 350, Gujarat, India, NDC 47335-738-86",
      "product_quantity": "35,235 bottles",
      "reason_for_recall": "Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.",
      "recall_initiation_date": "20150717",
      "center_classification_date": "20150814",
      "termination_date": "20160322",
      "report_date": "20150826",
      "code_info": "Lot #s: JKM4152A, JKM4737A, JKM5270A, Exp 08/2015",
      "more_code_info": ""
    }
  ]
}