{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Aurangabad, Maharashtra State",
      "state": "",
      "country": "India",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077259"
        ],
        "brand_name": [
          "TIMOLOL MALEATE"
        ],
        "generic_name": [
          "TIMOLOL MALEATE"
        ],
        "manufacturer_name": [
          "Rising Pharma Holdings, Inc."
        ],
        "product_ndc": [
          "64980-513",
          "64980-514"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "TIMOLOL MALEATE"
        ],
        "rxcui": [
          "1923428",
          "1992303"
        ],
        "spl_id": [
          "7ef88352-6fe4-48a4-b72b-15419d3ed051"
        ],
        "spl_set_id": [
          "2ed21930-1e05-46de-8acd-cb6f4798a7fa"
        ],
        "package_ndc": [
          "64980-513-05",
          "64980-513-01",
          "64980-513-15",
          "64980-514-05",
          "64980-514-01",
          "64980-514-15"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0364980513050",
          "0364980514057"
        ],
        "unii": [
          "P8Y54F701R"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95921",
      "recalling_firm": "FDC Limited",
      "address_1": "B-8 MIDC Industrial Area",
      "address_2": "Waluj District",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed to one Us Distributor in NJ.",
      "recall_number": "D-0114-2025",
      "product_description": "Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-513-15.",
      "product_quantity": "5184 bottles",
      "reason_for_recall": "Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.",
      "recall_initiation_date": "20241205",
      "center_classification_date": "20241206",
      "report_date": "20241218",
      "code_info": "Lot #: 083I006, Exp 08/31/2025",
      "more_code_info": ""
    }
  ]
}