{
  "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": "Terminated",
      "city": "Aurangabad, Maharashtra State",
      "state": "N/A",
      "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": "94466",
      "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": "New Jersey Only",
      "recall_number": "D-0488-2024",
      "product_description": "Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ",
      "product_quantity": "382,104 units",
      "reason_for_recall": "Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.",
      "recall_initiation_date": "20240425",
      "center_classification_date": "20240507",
      "termination_date": "20260521",
      "report_date": "20240515",
      "code_info": "Lot #: a) 083H008, Exp. Date 07/2025; 083G003, Exp. Date 06/2025; 083J017, Exp. Date 09/2025; b) 083I013, Exp. Date 08/2025."
    }
  ]
}