{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Glendora",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M018"
        ],
        "brand_name": [
          "OASIS TEARS PF"
        ],
        "generic_name": [
          "GLYCERIN"
        ],
        "manufacturer_name": [
          "OASIS Medical, Inc."
        ],
        "product_ndc": [
          "42126-6400"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "GLYCERIN"
        ],
        "rxcui": [
          "310541",
          "1598052"
        ],
        "spl_id": [
          "58c4a89f-c811-462c-a212-fa35c2e46864"
        ],
        "spl_set_id": [
          "640f95f4-c2e8-48ad-ad40-f76bbaddb0dc"
        ],
        "package_ndc": [
          "42126-6400-1"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000185370",
          "N0000175629",
          "N0000184306",
          "N0000185001",
          "M0000728",
          "M0009417"
        ],
        "pharm_class_epc": [
          "Non-Standardized Chemical Allergen [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]",
          "Increased IgG Production [PE]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]",
          "Glycerol [CS]"
        ],
        "unii": [
          "PDC6A3C0OX"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98897",
      "recalling_firm": "Oasis Medical, Inc.",
      "address_1": "510 S Vermont Ave # 528",
      "address_2": "",
      "postal_code": "91741-6205",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0525-2026",
      "product_description": "Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical, Inc., 514 S. Vermont Ave., Glendora, CA 91741, USA, Made in France, NDC 42126-6400-1.",
      "product_quantity": "",
      "reason_for_recall": "Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.",
      "recall_initiation_date": "20260427",
      "center_classification_date": "20260508",
      "report_date": "20260520",
      "code_info": "Lot # 1V59, Exp Date: 05/31/26; Lot # 3V12, 3V69, Exp Date: 08/31/26.",
      "more_code_info": ""
    }
  ]
}