{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA208699"
        ],
        "brand_name": [
          "EZETIMIBE AND SIMVASTATIN"
        ],
        "generic_name": [
          "EZETIMIBE AND SIMVASTATIN"
        ],
        "manufacturer_name": [
          "Glenmark Pharmaceuticals Inc., USA"
        ],
        "product_ndc": [
          "68462-321",
          "68462-322",
          "68462-323",
          "68462-324"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "EZETIMIBE",
          "SIMVASTATIN"
        ],
        "rxcui": [
          "476345",
          "476349",
          "476350",
          "476351"
        ],
        "spl_id": [
          "9c80244b-f111-425c-bf4c-c8cc91300cce"
        ],
        "spl_set_id": [
          "32d0e130-1211-44ca-be60-5379ffec96fd"
        ],
        "package_ndc": [
          "68462-321-90",
          "68462-321-10",
          "68462-321-30",
          "68462-322-30",
          "68462-322-90",
          "68462-322-10",
          "68462-323-30",
          "68462-323-90",
          "68462-323-05",
          "68462-324-30",
          "68462-324-90",
          "68462-324-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368462321300",
          "0368462322307",
          "0368462323304"
        ],
        "nui": [
          "N0000175589",
          "N0000000121",
          "N0000008553",
          "N0000175911"
        ],
        "pharm_class_epc": [
          "HMG-CoA Reductase Inhibitor [EPC]",
          "Dietary Cholesterol Absorption Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"
        ],
        "pharm_class_pe": [
          "Decreased Cholesterol Absorption [PE]"
        ],
        "unii": [
          "AGG2FN16EV",
          "EOR26LQQ24"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96884",
      "recalling_firm": "Glenmark Pharmaceuticals Inc., USA",
      "address_1": "750 Corporate Dr",
      "address_2": "",
      "postal_code": "07430-2009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide USA and PR",
      "recall_number": "D-0462-2025",
      "product_description": "Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-323-90",
      "product_quantity": "6,759 Con - 90 bottle pack",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.",
      "recall_initiation_date": "20250519",
      "center_classification_date": "20250610",
      "report_date": "20250618",
      "code_info": "Lot #: 17240195, Exp 01/31/2026.",
      "more_code_info": ""
    }
  ]
}