{
  "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": "2026-09-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Bedminster",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA214340"
        ],
        "brand_name": [
          "BROMFENAC SODIUM"
        ],
        "generic_name": [
          "BROMFENAC SODIUM"
        ],
        "manufacturer_name": [
          "Alembic Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "62332-583"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "BROMFENAC SODIUM"
        ],
        "rxcui": [
          "1375917"
        ],
        "spl_id": [
          "e680d513-20c9-4595-a293-d3f57d24f428"
        ],
        "spl_set_id": [
          "f6911061-d00e-466d-b623-f81730f38f98"
        ],
        "package_ndc": [
          "62332-583-03"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ECV571Y37"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98647",
      "recalling_firm": "ALEMBIC PHARMACEUTICALS, INC.",
      "address_1": "550 Hills Dr Ste 104b",
      "address_2": "",
      "postal_code": "07921-1537",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "",
      "product_description": "Bromfenac Ophthalmic Solution 0.07%, 3 ml, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Made in India, Manufactured by: Alembic Pharmaceuticals Limited, Karakhadi- 391 450, Gujarat, India NDC 62332-583-03.",
      "product_quantity": "",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing.",
      "recall_initiation_date": "20260318",
      "center_classification_date": "20260331",
      "report_date": "20260408",
      "code_info": "Lot # 7240184, 7240185, 7240186, 7240187, Exp Date: 3/31/2026; Lot # 7240278, Exp Date: 5/31/2026.",
      "more_code_info": ""
    }
  ]
}