{
  "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 III",
      "openfda": {
        "application_number": [
          "ANDA212450"
        ],
        "brand_name": [
          "LOTEPREDNOL ETABONATE"
        ],
        "generic_name": [
          "LOTEPREDNOL ETABONATE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "62756-232"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "LOTEPREDNOL ETABONATE"
        ],
        "rxcui": [
          "311382"
        ],
        "spl_id": [
          "567c4575-7310-9f12-e063-6294a90afee6"
        ],
        "spl_set_id": [
          "36cfd5b8-c892-44e1-aaed-fb32d7aeca7c"
        ],
        "package_ndc": [
          "62756-232-90",
          "62756-232-55",
          "62756-232-56"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0362756232907"
        ],
        "unii": [
          "YEH1EZ96K6"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92637",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "N/A",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA nationwide.",
      "recall_number": "D-0924-2023",
      "product_description": "Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC# 62756-232-55) and b) 15 mL bottle (NDC # 62756-232-56), Rx only, Distributed by: Sun Pharmaceutical Ind., Inc., NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Ltd., India.",
      "product_quantity": "20,884 cartons",
      "reason_for_recall": "Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.",
      "recall_initiation_date": "20230705",
      "center_classification_date": "20230717",
      "termination_date": "20240226",
      "report_date": "20230726",
      "code_info": "Lot#: a) BAC0334A, Exp 06/2023; BAC0532A, Exp 11/2023 BAD0407A, Exp 08/2024 BAD0425A, Exp 08/2024; b) BAC0335A, Exp 06/2023, BAC0533A, Exp 10/2023, BAD0148A, Exp 03/2024, BAD0320A, Exp 07/2024",
      "more_code_info": ""
    }
  ]
}