{
  "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": [
          "SYSTANE"
        ],
        "generic_name": [
          "HYPROMELLOSE"
        ],
        "manufacturer_name": [
          "Alcon Laboratories, Inc."
        ],
        "product_ndc": [
          "0065-0474"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "HYPROMELLOSE 2910 (4000 MPA.S)"
        ],
        "rxcui": [
          "310932"
        ],
        "spl_id": [
          "634b9bdb-004a-462e-ba48-1ab306157e02"
        ],
        "spl_set_id": [
          "5f74b161-ae41-d0e2-6ed9-8deca55d2c0f"
        ],
        "package_ndc": [
          "0065-0474-01",
          "0065-0474-02"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0300650474016"
        ],
        "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-0491-2026",
      "product_description": "Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01",
      "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#: 9T21, Exp Date: 4/30/2026; Lot# 1U63, 2U47, Exp Date: 5/31/2026; Lot# 6V00, 6V12, 8V54, Exp Date: 1/31/2027; Lot# 9V55, 8V58, 9V39, 9V97, Exp Date: 2/28/2027; Lot# 1W39, 1W40, Exp Date: 3/31/2027; Lot# 1X76, Exp Date: 4/30/2027.",
      "more_code_info": ""
    }
  ]
}