{
  "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": "New York",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M018"
        ],
        "brand_name": [
          "OPTASE"
        ],
        "generic_name": [
          "GLYCERIN"
        ],
        "manufacturer_name": [
          "Scope Health Inc"
        ],
        "product_ndc": [
          "72972-002"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "GLYCERIN"
        ],
        "rxcui": [
          "998232"
        ],
        "spl_id": [
          "49a44c61-bccb-ab89-e063-6394a90aa2b1"
        ],
        "spl_set_id": [
          "9e96976b-2990-79e0-e053-2995a90a0f29"
        ],
        "package_ndc": [
          "72972-002-01"
        ],
        "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": "98802",
      "recalling_firm": "SCOPE HEALTH",
      "address_1": "79 Madison Avenue",
      "address_2": "27 E 28th St",
      "postal_code": "10016-7921",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0499-2026",
      "product_description": "Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, Manufactured for Scope Health Inc., 79 Madison Ave., 8th Floor, New York, NY 10016, USA, NDC 72972-002-01.",
      "product_quantity": "",
      "reason_for_recall": "Lack of Assurance of Sterility",
      "recall_initiation_date": "20260420",
      "center_classification_date": "20260428",
      "report_date": "20260506",
      "code_info": "Lot#: 8T98, 9T31, 9T32, Exp. Date: 30/04/26; 2V13, 2V14, 2V15, Exp. Date 30/06/26; 3V35, Exp. Date 31/08/26;3V36, 3V37, Exp. Date 30/09/26;  5V45, 5V46, 9V12, Exp. Date 31/03/27; 1X57, 1X70, 1X84, Exp. Date 31/05/27.",
      "more_code_info": ""
    }
  ]
}