{
  "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": "Davie",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA201089"
        ],
        "brand_name": [
          "DICLOFENAC SODIUM AND MISOPROSTOL"
        ],
        "generic_name": [
          "DICLOFENAC SODIUM AND MISOPROSTOL"
        ],
        "manufacturer_name": [
          "Actavis Pharma, Inc."
        ],
        "product_ndc": [
          "0591-0397",
          "0591-0398"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DICLOFENAC SODIUM",
          "MISOPROSTOL"
        ],
        "rxcui": [
          "857706",
          "1359105"
        ],
        "spl_id": [
          "9d8d5f09-7764-4e55-87c6-d2fead0e6e97"
        ],
        "spl_set_id": [
          "df8b8660-0c24-4848-8bea-c1b935090c66"
        ],
        "package_ndc": [
          "0591-0397-60",
          "0591-0397-19",
          "0591-0398-60"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175785",
          "M0017811"
        ],
        "pharm_class_epc": [
          "Prostaglandin E1 Analog [EPC]"
        ],
        "pharm_class_cs": [
          "Prostaglandins E, Synthetic [CS]"
        ],
        "unii": [
          "QTG126297Q",
          "0E43V0BB57"
        ],
        "upc": [
          "305910398606"
        ]
      },
      "product_type": "Drugs",
      "event_id": "69495",
      "recalling_firm": "Actavis Laboratories, FL, Inc.",
      "address_1": "4955 Orange Dr",
      "address_2": "N/A",
      "postal_code": "33314-3902",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide including Puerto Rico.",
      "recall_number": "D-0258-2015",
      "product_description": "Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only. Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC: 0591-0398-60, UPC 3 05910 39860 6.",
      "product_quantity": "5,451 Bottles",
      "reason_for_recall": "Failed Tablet/Capsule Specifications: Presence of split or broken tablets.",
      "recall_initiation_date": "20140926",
      "center_classification_date": "20141121",
      "termination_date": "20150616",
      "report_date": "20141203",
      "code_info": "Lot # 694320A, Expiry: 02/28/2015.",
      "more_code_info": ""
    }
  ]
}