{
  "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": "Cranbury",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA206911"
        ],
        "brand_name": [
          "BROMSITE"
        ],
        "generic_name": [
          "BROMFENAC"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "49708-754"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "BROMFENAC SODIUM"
        ],
        "rxcui": [
          "1790141",
          "1790146"
        ],
        "spl_id": [
          "47daa628-c56f-1e9d-e063-6294a90a3d33"
        ],
        "spl_set_id": [
          "144a5072-341b-4591-8705-773b63044bcc"
        ],
        "package_ndc": [
          "49708-754-41"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ECV571Y37"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81958",
      "recalling_firm": "Sun Pharmaceutical Industries, Inc.",
      "address_1": "270 Prospect Plains Rd",
      "address_2": "N/A",
      "postal_code": "08512-3605",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0422-2019",
      "product_description": "BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 49708-754-41",
      "product_quantity": "69840 bottles",
      "reason_for_recall": "Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.",
      "recall_initiation_date": "20190124",
      "center_classification_date": "20190130",
      "termination_date": "20210222",
      "report_date": "20190206",
      "code_info": "Lot #: V18E01, Exp. 05/2020"
    }
  ]
}