{
  "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 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"
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        "spl_set_id": [
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        ],
        "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": "66380",
      "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",
      "recall_number": "D-1060-2014",
      "product_description": "Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 (60 count bottles)",
      "product_quantity": "6,540 bottles",
      "reason_for_recall": "Failed Tablet/Capsule Specifications: Broken tablets",
      "recall_initiation_date": "20130322",
      "center_classification_date": "20140203",
      "termination_date": "20150226",
      "report_date": "20140212",
      "code_info": "Lot 668271A, Exp 11/14 and Lot 684119A Exp 01/2015",
      "more_code_info": ""
    }
  ]
}