{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA206185"
        ],
        "brand_name": [
          "XELPROS"
        ],
        "generic_name": [
          "LATANOPROST"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "47335-317"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC",
          "TOPICAL"
        ],
        "substance_name": [
          "LATANOPROST"
        ],
        "rxcui": [
          "2056743",
          "2056748"
        ],
        "spl_id": [
          "44b8ddc0-81dc-4613-bbe8-0da960cc179c"
        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "47335-317-90",
          "47335-317-98",
          "47335-317-92",
          "47335-317-94"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175454",
          "M0017805"
        ],
        "pharm_class_epc": [
          "Prostaglandin Analog [EPC]"
        ],
        "pharm_class_cs": [
          "Prostaglandins [CS]"
        ],
        "unii": [
          "6Z5B6HVF6O"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94465",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "TX, PA",
      "recall_number": "D-0502-2024",
      "product_description": "Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., India., NDC 47335-317-90",
      "product_quantity": "35,069 bottles",
      "reason_for_recall": "Failed Release Testing: Out of specification for particulate matter test.",
      "recall_initiation_date": "20240422",
      "center_classification_date": "20240520",
      "report_date": "20240529",
      "code_info": "Lot #: HAD3383A, Exp 8/31/2024",
      "more_code_info": ""
    }
  ]
}