{
  "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": "Terminated",
      "city": "Camarillo",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA200909"
        ],
        "brand_name": [
          "EZETIMIBE AND SIMVASTATIN"
        ],
        "generic_name": [
          "EZETIMIBE AND SIMVASTATIN"
        ],
        "manufacturer_name": [
          "Golden State Medical Supply, Inc."
        ],
        "product_ndc": [
          "51407-190",
          "51407-191",
          "51407-192",
          "51407-193"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "EZETIMIBE",
          "SIMVASTATIN"
        ],
        "rxcui": [
          "476345",
          "476349",
          "476350",
          "476351"
        ],
        "spl_id": [
          "446023ff-25b4-2c12-e063-6294a90ad27e"
        ],
        "spl_set_id": [
          "88cd0e7b-e8dc-6125-e053-2a95a90aaa27"
        ],
        "package_ndc": [
          "51407-190-30",
          "51407-190-90",
          "51407-190-10",
          "51407-191-30",
          "51407-191-90",
          "51407-191-10",
          "51407-192-30",
          "51407-192-90",
          "51407-192-05",
          "51407-192-10",
          "51407-193-30",
          "51407-193-90",
          "51407-193-05"
        ],
        "original_packager_product_ndc": [
          "43598-742",
          "43598-744",
          "43598-743",
          "43598-745"
        ],
        "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": "88866",
      "recalling_firm": "Golden State Medical Supply Inc.",
      "address_1": "5187 Camino Ruiz",
      "address_2": "N/A",
      "postal_code": "93012-8601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed to two distributors located in AZ and MO",
      "recall_number": "D-0228-2022",
      "product_description": "Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC 51407-193-05",
      "product_quantity": "49",
      "reason_for_recall": "Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity",
      "recall_initiation_date": "20211014",
      "center_classification_date": "20211109",
      "termination_date": "20221110",
      "report_date": "20211117",
      "code_info": "GS040048, Exp: 1/2023",
      "more_code_info": ""
    }
  ]
}