{
  "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": "Vasco Da Gama",
      "state": "N/A",
      "country": "India",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077917"
        ],
        "brand_name": [
          "PRAVASTATIN SODIUM"
        ],
        "generic_name": [
          "PRAVASTATIN SODIUM"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "68180-485",
          "68180-486",
          "68180-487",
          "68180-488"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PRAVASTATIN SODIUM"
        ],
        "rxcui": [
          "904458",
          "904467",
          "904475",
          "904481"
        ],
        "spl_id": [
          "a173dd76-57cb-4066-a51f-26adfb79e861"
        ],
        "spl_set_id": [
          "1123d56c-16f0-4f81-b56f-67b1f343ae1e"
        ],
        "package_ndc": [
          "68180-485-03",
          "68180-485-09",
          "68180-485-02",
          "68180-486-09",
          "68180-486-02",
          "68180-486-03",
          "68180-487-09",
          "68180-487-02",
          "68180-487-03",
          "68180-488-09",
          "68180-488-02",
          "68180-488-03"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368180487098"
        ],
        "unii": [
          "3M8608UQ61"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78566",
      "recalling_firm": "Lupin Limited",
      "address_1": "15 - B I Phase 1a",
      "address_2": "I D C Verna Industrial Road",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed throughout the United States, including Puerto Rico.",
      "recall_number": "D-0092-2018",
      "product_description": "Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-487-09",
      "product_quantity": "N/A",
      "reason_for_recall": "Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium Tablets USP, 40mg bottle.",
      "recall_initiation_date": "20171117",
      "center_classification_date": "20171121",
      "termination_date": "20190315",
      "report_date": "20171129",
      "code_info": "Lot # G702459, Exp 2/20"
    }
  ]
}