{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA200909"
        ],
        "brand_name": [
          "EZETIMIBE AND SIMVASTATIN"
        ],
        "generic_name": [
          "EZETIMIBE AND SIMVASTATIN"
        ],
        "manufacturer_name": [
          "Dr.Reddys Laboratories Inc"
        ],
        "product_ndc": [
          "43598-742",
          "43598-744",
          "43598-743",
          "43598-745"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "EZETIMIBE",
          "SIMVASTATIN"
        ],
        "rxcui": [
          "476345",
          "476349",
          "476350",
          "476351"
        ],
        "spl_id": [
          "697ae8a7-2359-455f-9c21-e266f1c31288"
        ],
        "spl_set_id": [
          "023ca87a-1b04-8c17-dc4f-e2758b0771e2"
        ],
        "package_ndc": [
          "43598-742-30",
          "43598-742-90",
          "43598-742-10",
          "43598-744-30",
          "43598-744-90",
          "43598-744-10",
          "43598-743-30",
          "43598-743-90",
          "43598-743-05",
          "43598-745-30",
          "43598-745-90",
          "43598-745-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0343598745909",
          "0343598742908",
          "0343598743905",
          "0343598744902"
        ],
        "nui": [
          "N0000008553",
          "N0000175911",
          "N0000175589",
          "N0000000121"
        ],
        "pharm_class_pe": [
          "Decreased Cholesterol Absorption [PE]"
        ],
        "pharm_class_epc": [
          "Dietary Cholesterol Absorption Inhibitor [EPC]",
          "HMG-CoA Reductase Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"
        ],
        "unii": [
          "EOR26LQQ24",
          "AGG2FN16EV"
        ]
      },
      "product_type": "Drugs",
      "event_id": "88798",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "N/A",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the US",
      "recall_number": "D-0085-2022",
      "product_description": "Dr. Reddy's  Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA NDC 43598-743-05",
      "product_quantity": "696 bottles",
      "reason_for_recall": "Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle",
      "recall_initiation_date": "20211005",
      "center_classification_date": "20211029",
      "termination_date": "20230216",
      "report_date": "20211110",
      "code_info": "L100208, exp 01/2023"
    }
  ]
}