{
  "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": "Richmond",
      "state": "VA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M018"
        ],
        "brand_name": [
          "SYSTANE LUBRICANT"
        ],
        "generic_name": [
          "POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL"
        ],
        "manufacturer_name": [
          "Alcon Laboratories, Inc."
        ],
        "product_ndc": [
          "0065-0429"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "POLYETHYLENE GLYCOL 400",
          "PROPYLENE GLYCOL"
        ],
        "rxcui": [
          "477589"
        ],
        "spl_id": [
          "bbb16c95-87ac-4e07-8060-5e33e6dae0a6"
        ],
        "spl_set_id": [
          "15bc06ec-f3dc-3180-ca1a-106769a770ea"
        ],
        "package_ndc": [
          "0065-0429-15",
          "0065-0429-21",
          "0065-0429-30",
          "0065-0429-36",
          "0065-0429-67",
          "0065042915",
          "0065042930"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "B697894SGQ",
          "6DC9Q167V3"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90553",
      "recalling_firm": "Mckesson Medical-Surgical Inc. Corporate Office",
      "address_1": "9954 Maryland Drive",
      "address_2": "Deep Run Iii Ste. 4000",
      "postal_code": "23233",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA.",
      "recall_number": "D-1314-2022",
      "product_description": "Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry Eye Relief, Sterile, a) 15 mL (0.5 FL OZ) NDC 0065-0429-15, b) 30 mL (1 FL OZ) NDC 0065-0429-30, bottle per box, Alcon Surgical Inc.",
      "product_quantity": "47 bottles",
      "reason_for_recall": "CGMP Deviations: products were stored outside the drug label specifications.",
      "recall_initiation_date": "20220629",
      "center_classification_date": "20220805",
      "termination_date": "20240213",
      "report_date": "20220817",
      "code_info": "Part# a) 0065042915, b) 0065042930",
      "more_code_info": ""
    }
  ]
}