{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Baltimore",
      "state": "MD",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA078296"
        ],
        "brand_name": [
          "LOVASTATIN"
        ],
        "generic_name": [
          "LOVASTATIN"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "68180-467",
          "68180-468",
          "68180-469"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LOVASTATIN"
        ],
        "rxcui": [
          "197903",
          "197904",
          "197905"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
          "df7ddf4f-d569-431e-81f1-9129d7043150"
        ],
        "package_ndc": [
          "68180-467-09",
          "68180-467-07",
          "68180-467-01",
          "68180-467-03",
          "68180-467-05",
          "68180-468-07",
          "68180-468-01",
          "68180-468-03",
          "68180-468-05",
          "68180-468-09",
          "68180-469-07",
          "68180-469-01",
          "68180-469-03",
          "68180-469-05",
          "68180-469-09"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368180469070",
          "0368180467076",
          "0368180468073"
        ],
        "nui": [
          "N0000175589",
          "N0000000121"
        ],
        "pharm_class_epc": [
          "HMG-CoA Reductase Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"
        ],
        "unii": [
          "9LHU78OQFD"
        ]
      },
      "product_type": "Drugs",
      "event_id": "82126",
      "recalling_firm": "Lupin Pharmaceuticals Inc.",
      "address_1": "111 S Calvert St Fl 21ST",
      "address_2": "",
      "postal_code": "21202-6174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA and Puerto Rico.",
      "recall_number": "D-0513-2019",
      "product_description": "Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA.",
      "product_quantity": "44,640 bottles",
      "reason_for_recall": "CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.",
      "recall_initiation_date": "20190213",
      "center_classification_date": "20190220",
      "termination_date": "20201006",
      "report_date": "20190227",
      "code_info": "Lot #: a) G702755, Exp March 2020; b) G702756, Exp March 2020",
      "more_code_info": ""
    }
  ]
}