{
  "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": "Weston",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077090"
        ],
        "brand_name": [
          "LEFLUNOMIDE"
        ],
        "generic_name": [
          "LEFLUNOMIDE"
        ],
        "manufacturer_name": [
          "Apotex Corp."
        ],
        "product_ndc": [
          "60505-2502",
          "60505-2503"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LEFLUNOMIDE"
        ],
        "rxcui": [
          "205284",
          "205285"
        ],
        "spl_id": [
          "ebee26d4-bf2a-e0eb-b0f4-e1212d0bed03"
        ],
        "spl_set_id": [
          "753453c5-8a7a-878e-3ce7-1d1edce718a9"
        ],
        "package_ndc": [
          "60505-2502-1",
          "60505-2502-2",
          "60505-2502-3",
          "60505-2503-1",
          "60505-2503-2",
          "60505-2503-3"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175713"
        ],
        "pharm_class_epc": [
          "Antirheumatic Agent [EPC]"
        ],
        "unii": [
          "G162GK9U4W"
        ]
      },
      "product_type": "Drugs",
      "event_id": "38329",
      "recalling_firm": "Apotex Corp.",
      "address_1": "2400 N Commerce Pkwy",
      "address_2": "Ste 400",
      "postal_code": "33326-3253",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "FAX",
      "distribution_pattern": "Nationwide.",
      "recall_number": "D-1661-2012",
      "product_description": "Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 60505-2502-3), Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9",
      "product_quantity": "3063",
      "reason_for_recall": "Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.",
      "recall_initiation_date": "20070614",
      "center_classification_date": "20120827",
      "termination_date": "20120828",
      "report_date": "20120905",
      "code_info": "Lot #: a) GY4197, Exp 11/07; b) GZ1273, Exp 11/07."
    }
  ]
}