{
  "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": "Bristol",
      "state": "TN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA021301"
        ],
        "brand_name": [
          "LEVOXYL"
        ],
        "generic_name": [
          "LEVOTHYROXINE SODIUM"
        ],
        "manufacturer_name": [
          "Pfizer Laboratories Div Pfizer Inc"
        ],
        "product_ndc": [
          "60793-850",
          "60793-851",
          "60793-852",
          "60793-853",
          "60793-854",
          "60793-855",
          "60793-856",
          "60793-857",
          "60793-858",
          "60793-859",
          "60793-860"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LEVOTHYROXINE SODIUM"
        ],
        "rxcui": [
          "892246",
          "892251",
          "966157",
          "966164",
          "966170",
          "966175",
          "966184",
          "966190",
          "966194",
          "966200",
          "966204",
          "966211",
          "966220",
          "966221",
          "966222",
          "966224",
          "966225",
          "966248",
          "966249",
          "966253",
          "966270",
          "966283"
        ],
        "spl_id": [
          "e230c170-2a16-47d0-bce7-ac0414c192f7"
        ],
        "spl_set_id": [
          "758588c3-c63e-491b-0aa2-4f50d80cb174"
        ],
        "package_ndc": [
          "60793-850-10",
          "60793-850-01",
          "60793-851-10",
          "60793-851-01",
          "60793-852-10",
          "60793-852-01",
          "60793-853-10",
          "60793-853-01",
          "60793-854-10",
          "60793-854-01",
          "60793-855-10",
          "60793-855-01",
          "60793-856-10",
          "60793-856-01",
          "60793-857-10",
          "60793-857-01",
          "60793-858-10",
          "60793-858-01",
          "60793-859-10",
          "60793-859-01",
          "60793-860-10",
          "60793-860-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0360793856018",
          "0360793850016",
          "0360793852010",
          "0360793851013",
          "0360793857015",
          "0360793853017",
          "0360793854014",
          "0360793858012",
          "0360793855011",
          "0360793859019",
          "0360793860015"
        ],
        "unii": [
          "9J765S329G"
        ]
      },
      "product_type": "Drugs",
      "event_id": "65172",
      "recalling_firm": "King Legacy, a wholly owned subsidiary of Pfizer",
      "address_1": "501 5th Street",
      "address_2": "N/A",
      "postal_code": "37620-2304",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-424-2013",
      "product_description": "Levoxyl (levothyroxine sodium) tablets, USP, 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles (NDC 60793-853-10), Rx only, Manufactured and Distributed by:  King Pharmaceuticals, Inc., Bristol, TN  37620",
      "product_quantity": "112,914 bottles",
      "reason_for_recall": "Subpotent Drug: The products were below specification for potency at the expiry stability point.",
      "recall_initiation_date": "20130430",
      "center_classification_date": "20130520",
      "termination_date": "20160630",
      "report_date": "20130529",
      "code_info": "Lot # a) 64935, Exp. 5/13; 65239, Exp. 6/13; 65900, Exp. 8/13; 66370, Exp. 10/13; and 66391, Exp. 9/13; b) 64927, Exp. 5/13; and 65240, Exp. 6/13"
    }
  ]
}