{
  "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": "Columbus",
      "state": "OH",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA078296"
        ],
        "brand_name": [
          "LOVASTATIN"
        ],
        "generic_name": [
          "LOVASTATIN"
        ],
        "manufacturer_name": [
          "BluePoint Laboratories"
        ],
        "product_ndc": [
          "68001-314",
          "68001-315",
          "68001-316"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LOVASTATIN"
        ],
        "rxcui": [
          "197903",
          "197904",
          "197905"
        ],
        "spl_id": [
          "26682060-6c21-5cd7-e063-6394a90ab4dd"
        ],
        "spl_set_id": [
          "7b86160d-74a9-4774-b5b3-5641e686991f"
        ],
        "package_ndc": [
          "68001-314-00",
          "68001-314-08",
          "68001-315-00",
          "68001-315-08",
          "68001-316-00",
          "68001-316-08"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368001316002",
          "0368001314008",
          "0368001315005"
        ],
        "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": "83471",
      "recalling_firm": "American Health Packaging",
      "address_1": "2550 John Glenn Ave Ste A",
      "address_2": "N/A",
      "postal_code": "43217-1188",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the USA and Puerto Rico",
      "recall_number": "D-1584-2019",
      "product_description": "Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-316-08), Rx Only, Manufactured by: Lupin Limited, Goa 403 722 INDIA For BluePoint Laboratories.",
      "product_quantity": "14,360 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": "20190219",
      "center_classification_date": "20190802",
      "termination_date": "20200909",
      "report_date": "20190814",
      "code_info": "Lot #: a) G702705 and b) G702706, Exp. 3/31/2020"
    }
  ]
}