{
  "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": "Pomona",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M018"
        ],
        "brand_name": [
          "QUALITY CHOICE EYE DROPS IRRITATION RELIEF",
          "GOODSENSE ULTRA LUBRICANT EYE DROPS",
          "MEIJER SEASONAL ITCHING AND REDNESS RELIEF"
        ],
        "generic_name": [
          "TETRAHYDROZOLINE HCL, ZINC SULFATE",
          "POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL",
          "TETRAHYDROZOLINE HCI, ZINC SULFATE"
        ],
        "manufacturer_name": [
          "Quality Choice",
          "Geiss, Destin & Dunn, Inc.",
          "Meijer Distribution, Inc."
        ],
        "product_ndc": [
          "83324-190",
          "50804-160",
          "41250-598"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "TETRAHYDROZOLINE HYDROCHLORIDE",
          "ZINC SULFATE",
          "POLYETHYLENE GLYCOL 400",
          "PROPYLENE GLYCOL"
        ],
        "rxcui": [
          "1043249",
          "477589"
        ],
        "spl_id": [
          "4749597d-57d7-92b6-e063-6294a90ab574",
          "474511c4-1fbd-70b8-e063-6294a90af8e8",
          "0d22c2c2-a705-2509-e063-6294a90ae206"
        ],
        "spl_set_id": [
          "1f682079-6e91-e14b-e063-6394a90a3f12",
          "9b45ebb5-c43b-c9fb-e053-2a95a90a3411",
          "9fead2de-2fe6-4dab-e053-2995a90a2742"
        ],
        "package_ndc": [
          "83324-190-14",
          "50804-160-01",
          "41250-598-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0635515995055",
          "0846036008210",
          "0041250829188",
          "070038470106",
          "093351011580",
          "311917179544",
          "041163251144",
          "036800036406",
          "041220437467"
        ],
        "unii": [
          "0YZT43HS7D",
          "89DS0H96TB",
          "B697894SGQ",
          "6DC9Q167V3"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98533",
      "recalling_firm": "K.C. Pharmaceuticals, Inc",
      "address_1": "3420 Pomona Blvd",
      "address_2": "",
      "postal_code": "91768-3236",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide in the US",
      "recall_number": "D-0409-2026",
      "product_description": "Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, UPC 0 70038 47010 6; b) QC-Quality Choice, Sterile Eye drops Irritation Relief, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-190-14; c) Discount drug mart, Eye Drops A.C., Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01158 0; d) Good Sense Sterile Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-160-01; e) Walgreens, Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 17954 4; f) CAREONE, Itchy relief Eye drops, DISTRIBUTED BY: FOODHOLD U.S.A, LLC., LANDOVER, MD 20785;  g) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 25114 4; h) TopCare health TM, DISTRIBUTED BY: TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, UPC 0 36800 03640 6; i) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-598-01; j) H.E.B A.C. Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43746 7",
      "product_quantity": "182,424 bottles",
      "reason_for_recall": "Lack of Assurance of Sterility",
      "recall_initiation_date": "20260303",
      "center_classification_date": "20260331",
      "report_date": "20260408",
      "code_info": "Lot: a) AC24E01, Exp.: 05/31/26; b) AC24E01, Exp.: 05/31/26; c) AC24E01, Exp.: 05/31/26; d) AC24E01, Exp.: 05/31/26; e) AC24E01, Exp.: 05/31/26; f) AC24E01, Exp.: 05/31/26; g) AC24E01, Exp.: 05/31/26; h)AC24E01, Exp.: 05/31/26; i) AC24E01, Exp.: 05/31/26; j) AC24E01, Exp.: 05/31/26;",
      "more_code_info": ""
    }
  ]
}