{
  "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": "N/A",
      "country": "India",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077568"
        ],
        "brand_name": [
          "CIPROFLOXACIN"
        ],
        "generic_name": [
          "CIPROFLOXACIN"
        ],
        "manufacturer_name": [
          "Leading Pharma, LLC"
        ],
        "product_ndc": [
          "69315-308"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "CIPROFLOXACIN HYDROCHLORIDE"
        ],
        "rxcui": [
          "309307"
        ],
        "spl_id": [
          "8217ec14-6498-4c35-a5a9-511b451b9459"
        ],
        "spl_set_id": [
          "545527e7-05c7-4dbf-ab32-b3fa463d55b0"
        ],
        "package_ndc": [
          "69315-308-02",
          "69315-308-05",
          "69315-308-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0369315308028",
          "0369315308059"
        ],
        "unii": [
          "4BA73M5E37"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96495",
      "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": "Nationwide in the U.S",
      "recall_number": "D-0282-2025",
      "product_description": "Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05",
      "product_quantity": "90960 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": "20250311",
      "center_classification_date": "20250317",
      "report_date": "20250326",
      "code_info": "Lot: 084A067, Exp 12/31/2025"
    }
  ]
}