{
  "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": "2026-05-06",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Fort Worth",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M018"
        ],
        "brand_name": [
          "GENTEAL TEARS"
        ],
        "generic_name": [
          "HYPROMELLOSE"
        ],
        "manufacturer_name": [
          "Alcon Laboratories, Inc."
        ],
        "product_ndc": [
          "0065-8064"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "HYPROMELLOSE 2910 (4000 MPA.S)"
        ],
        "rxcui": [
          "310932",
          "793204"
        ],
        "spl_id": [
          "750c99c5-ade3-4759-870b-cb59248e9fa0"
        ],
        "spl_set_id": [
          "a57854fc-f3a2-4fbb-b718-cd06f87a721e"
        ],
        "package_ndc": [
          "0065-8064-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0300658064011"
        ],
        "unii": [
          "RN3152OP35"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98815",
      "recalling_firm": "Alcon Research LLC",
      "address_1": "6201 South Fwy",
      "address_2": "",
      "postal_code": "76134-2099",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0492-2026",
      "product_description": "GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0065-8064-01.",
      "product_quantity": "",
      "reason_for_recall": "Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.",
      "recall_initiation_date": "20260421",
      "center_classification_date": "20260424",
      "report_date": "20260506",
      "code_info": "Lot #: 9T20, 9T50, 9T59, 1U30, 1U48, Exp Date: 4/30/2026; 4V15, Exp Date: 8/31/2026;  7V61, Exp Date: 12/31/2026; 1W47, 1W49, 1X14, Exp Date: 3/31/2027.",
      "more_code_info": ""
    }
  ]
}