{
  "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"
        ]
      },
      "product_type": "Drugs",
      "event_id": "65541",
      "recalling_firm": "Watson Laboratories, Inc.-(Actavis) - Florida",
      "address_1": "4955 Orange Dr",
      "address_2": "N/A",
      "postal_code": "33314-3902",
      "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-817-2013",
      "product_description": "Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60",
      "product_quantity": "392,400 tablets",
      "reason_for_recall": "Failed Tablet/Capsule Specifications: Broken tablets",
      "recall_initiation_date": "20130322",
      "center_classification_date": "20130723",
      "termination_date": "20140925",
      "report_date": "20130731",
      "code_info": "Lot 635098A, Exp 10/14",
      "more_code_info": ""
    }
  ]
}