{
  "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": "Warren",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA211776"
        ],
        "brand_name": [
          "DIFLUPREDNATE"
        ],
        "generic_name": [
          "DIFLUPREDNATE"
        ],
        "manufacturer_name": [
          "Cipla USA Inc."
        ],
        "product_ndc": [
          "69097-341"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "DIFLUPREDNATE"
        ],
        "rxcui": [
          "804544"
        ],
        "spl_id": [
          "825a55a7-ffdf-4fde-bbb2-486cbd16e602"
        ],
        "spl_set_id": [
          "8a7254de-a7a2-476d-9295-c41926267ec9"
        ],
        "package_ndc": [
          "69097-341-35"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "S8A06QG2QE"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90796",
      "recalling_firm": "CIPLA",
      "address_1": "10 Independence Blvd",
      "address_2": "N/A",
      "postal_code": "07059-2730",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-1499-2022",
      "product_description": "Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.",
      "product_quantity": "117,844 bottles",
      "reason_for_recall": "Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.",
      "recall_initiation_date": "20220822",
      "center_classification_date": "20220907",
      "termination_date": "20231127",
      "report_date": "20220914",
      "code_info": "Lot #: DEG1HC2, DEG2HC2, DEG3HC2, DEG4HC2, DEG5HC2, DEG6HC2, Exp 01/2023; DEG1IC2,   DEG2IC2, DEG3IC2, DEG4IC2, Exp 02/2023; DEG1LC2, DEG2LC2, Exp 05/2023; DEG1BD2, DEG2BD2, DEG3BD2, Exp 07/2023"
    }
  ]
}