{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Tampa",
      "state": "FL",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA202872"
        ],
        "brand_name": [
          "LOTEMAX"
        ],
        "generic_name": [
          "LOTEPREDNOL ETABONATE"
        ],
        "manufacturer_name": [
          "Bausch & Lomb Incorporated"
        ],
        "product_ndc": [
          "24208-503"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "LOTEPREDNOL ETABONATE"
        ],
        "rxcui": [
          "1312625",
          "1312627"
        ],
        "spl_id": [
          "253b0a9d-16fe-2eb1-e063-6294a90ac5e0"
        ],
        "spl_set_id": [
          "9a666065-d467-42b8-8ecd-0ec1de9986d5"
        ],
        "package_ndc": [
          "24208-503-07",
          "24208-503-48",
          "24208-503-96"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "YEH1EZ96K6"
        ]
      },
      "product_type": "Drugs",
      "event_id": "83093",
      "recalling_firm": "Bausch & Lomb",
      "address_1": "8500 Hidden River Pkwy",
      "address_2": "N/A",
      "postal_code": "33637-1014",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the U.S.",
      "recall_number": "D-1396-2019",
      "product_description": "Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, NDC 24208-503-07.",
      "product_quantity": "170832 bottles",
      "reason_for_recall": "Failed Stability Specifications: Out of specification for viscosity.",
      "recall_initiation_date": "20190617",
      "center_classification_date": "20190619",
      "termination_date": "20210924",
      "report_date": "20190619",
      "code_info": "Lot #s: 282611; 283431; 283441; 283451, Exp. 10/2019; 282971; 282981; 283611; 283621; 283631, Exp. 11/2019."
    }
  ]
}