{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Hyderabad",
      "state": "",
      "country": "India",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA204598"
        ],
        "brand_name": [
          "FENOFIBRATE"
        ],
        "generic_name": [
          "FENOFIBRATE"
        ],
        "manufacturer_name": [
          "Camber Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "31722-595",
          "31722-596"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FENOFIBRATE"
        ],
        "rxcui": [
          "477560",
          "477562"
        ],
        "spl_id": [
          "3a0bacd4-7a48-214e-e063-6394a90ac69f"
        ],
        "spl_set_id": [
          "38f43148-4ca0-402a-ba39-8ee5011a7907"
        ],
        "package_ndc": [
          "31722-595-30",
          "31722-595-90",
          "31722-595-31",
          "31722-595-32",
          "31722-596-30",
          "31722-596-90",
          "31722-596-31",
          "31722-596-32"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0331722596305",
          "0331722595308"
        ],
        "nui": [
          "N0000175596",
          "N0000175375",
          "M0543661"
        ],
        "pharm_class_epc": [
          "Peroxisome Proliferator Receptor alpha Agonist [EPC]"
        ],
        "pharm_class_moa": [
          "Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]"
        ],
        "pharm_class_cs": [
          "Fibric Acids [CS]"
        ],
        "unii": [
          "U202363UOS"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81017",
      "recalling_firm": "Hetero Labs, Ltd. - Unit III",
      "address_1": "Plot 22-110, Part Ii, Ida",
      "address_2": "Rangareddy, Jeedimetla",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Indiana and Louisiana",
      "recall_number": "D-1211-2018",
      "product_description": "Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90",
      "product_quantity": "5,424 bottles",
      "reason_for_recall": "Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.",
      "recall_initiation_date": "20180912",
      "center_classification_date": "20180925",
      "termination_date": "20181129",
      "report_date": "20181003",
      "code_info": "Lot #:  E181370, Exp. 5/2020",
      "more_code_info": ""
    }
  ]
}