{
  "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": "2026-08-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Tarrytown",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M018"
        ],
        "brand_name": [
          "CLEAR EYES MAXIMUM ITCHY EYE RELIEF"
        ],
        "generic_name": [
          "GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE AND ZINC SULFATE"
        ],
        "manufacturer_name": [
          "Prestige Brands Holdings, Inc."
        ],
        "product_ndc": [
          "67172-999"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "GLYCERIN",
          "NAPHAZOLINE HYDROCHLORIDE",
          "ZINC SULFATE"
        ],
        "rxcui": [
          "1046644"
        ],
        "spl_id": [
          "4ed44e8e-1743-4724-83ce-d6d1c69677f5"
        ],
        "spl_set_id": [
          "326a1462-78d1-42d6-8257-7e4f00d1f215"
        ],
        "package_ndc": [
          "67172-999-01",
          "67172-999-06"
        ],
        "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",
          "MZ1131787D",
          "89DS0H96TB"
        ],
        "upc": [
          "678112659203"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99532",
      "recalling_firm": "Prestige Brands Holdings",
      "address_1": "660 White Plains Rd",
      "address_2": "",
      "postal_code": "10591-5139",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA.",
      "recall_number": "D-0766-2026",
      "product_description": "CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Consumer Healthcare Company.  NDC: 67172-999-01 UPC 6 78112 65920 3",
      "product_quantity": "39,060 15mL-bottles",
      "reason_for_recall": "Lack of assurance of sterility. The recall is due to potential contamination",
      "recall_initiation_date": "20260729",
      "center_classification_date": "20260814",
      "report_date": "20260819",
      "code_info": "Lot 2552A, Exp 09/30/2027",
      "more_code_info": ""
    }
  ]
}