{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Allegan",
      "state": "MI",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA078336"
        ],
        "brand_name": [
          "EQUALINE ALL DAY ALLERGY",
          "GOOD NEIGHBOR PHARMACY ALL DAY ALLERGY",
          "REXALL ALL DAY ALLERGY RELIEF",
          "ALLERGY RELIEF",
          "TOPCARE ALL DAY ALLERGY"
        ],
        "generic_name": [
          "CETIRIZINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "United Natural Foods, Inc. dba UNFI",
          "Amerisource Bergen",
          "Dolgencorp, LLC",
          "CVS Pharmacy",
          "Topco Associates LLC"
        ],
        "product_ndc": [
          "41163-458",
          "24385-998",
          "55910-699",
          "59779-458",
          "36800-458"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CETIRIZINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1014678"
        ],
        "spl_id": [
          "6e7bab3d-af1a-4b74-921d-99aca2aa0fd3",
          "49064fc4-3c0c-4d8f-9576-f57ad03f9cfe",
          "eba98b0b-bc85-4d05-8875-86b85bd462b4",
          "131dd209-e1fe-4dd4-9523-8c0da50b78f4",
          "dc4e4803-536c-4a2b-9faa-e307a66eb91a"
        ],
        "spl_set_id": [
          "491fae66-83b6-4beb-945b-39b9e4e021c5",
          "c568e388-60ab-47be-b362-7832b83d06ad",
          "4d79fb74-1895-4efe-8016-c0dd5ed10f7a",
          "98f3f2c6-da18-4055-81f1-962261360f9b",
          "f2919aad-9ed4-40b8-b233-4aec06df33ea"
        ],
        "package_ndc": [
          "41163-458-39",
          "41163-458-66",
          "41163-458-72",
          "41163-458-76",
          "41163-458-95",
          "41163-458-58",
          "24385-998-74",
          "24385-998-65",
          "24385-998-75",
          "24385-998-58",
          "55910-699-66",
          "59779-458-13",
          "59779-458-39",
          "59779-458-95",
          "59779-458-75",
          "59779-458-76",
          "59779-458-88",
          "59779-458-66",
          "59779-458-72",
          "59779-458-70",
          "59779-458-58",
          "59779-458-06",
          "59779-458-00",
          "59779-458-05",
          "59779-458-01",
          "36800-458-13",
          "36800-458-66",
          "36800-458-39",
          "36800-458-95",
          "36800-458-72",
          "36800-458-75",
          "36800-458-47",
          "36800-458-87",
          "36800-458-06",
          "36800-458-58",
          "37808-458-66",
          "3700306594",
          "42507-458-66",
          "49738-458-66",
          "30142-458-66",
          "49781-106-14",
          "55316-458-66",
          "21130-458-66",
          "0363-0495-66",
          "46994-458-66",
          "41520-458-66",
          "41190-458-66",
          "0411902233",
          "37012-458-66",
          "3700306776",
          "55312-458-66",
          "0154001210"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "64O047KTOA"
        ],
        "upc": [
          "370030659432",
          "041190223343",
          "370030677689",
          "015400121026"
        ]
      },
      "product_type": "Drugs",
      "event_id": "72505",
      "recalling_firm": "Perrigo Company PLC",
      "address_1": "515 Eastern Ave",
      "address_2": "N/A",
      "postal_code": "49010-9070",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0525-2016",
      "product_description": "Cetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter under the following brands, GoodSense brand distributed by Perrigo, Allegan, MI; Equaline brand distributed by; Supervalu Inc, Eden Prairie, MN (NDC 41163-458-66); Good Neighbor Pharmacy brand, distributed by AmerisourceBergen, Chesterbrook, PA (NDC 24385-998-74); HEB brand, San Antonio, TX (NDC 37808-458-66); Rexall brand Packaged for Dolgencorp LLC, Goodlettsville, TN (NDC 55910-699-66 UPC: 370030659432), HyVee brand, distributed by Hy-Vee Inc., West Des Mones, IA (NDC 42507-458-66); Smart Sense brand distributed by Kmart Corporation, Hoffman Estates, IL (NDC 49738-458-66); Kroger brand distributed by The Kroger Co, Cincinnati, OH (NDC 30142-458-66); Leader brand distributed by Cardinal Health, Dublin, OH (NDC 49781-106-14; CVS Pharmacy brand distributed by CVS Pharmacy, Inc., Woonsocket, RI (NDC 59779-458-66); Healthy Accents brand distributed by DZA Brands, LLC, Salisbury, NC (NDC 55316-458-66); Safeway Care brand distributed by Safeway Inc., Pleasanton, CA (NDC 21130-458-66); Topcare brand distributed by Topsco Associates, LLC, Skokie, IL (NDC 36800-458-66); Wal-Zyr brand distributed by Walgreens Co, Deerfield, IL (NDC 0363-0495-66); Being Well brand distributed by Save-A-Lot Food Stores, Ltd, Earth City, MO (NDC 46994-458-66); CareOne brand distributed by FoodHold, USA LLC, Landover, MD (NDC 41520-458-66); Shoprite brand distributed by Wakefern Food, Corp, Keasbey, NJ (NDC 41190-458-66 UPC: 041190223343); Shopko brand distributed by Shopko Stores Operating Co., LLC, Green Bay, WI (NDC 37012-458-66 UPC: 370030677689); Western Family brand distributed by Western Family Foods, Inc., Portland, OR (NDC 55312-458-66 UPC: 015400121026)",
      "product_quantity": "209,256 cartons",
      "reason_for_recall": "Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester",
      "recall_initiation_date": "20150928",
      "center_classification_date": "20151224",
      "termination_date": "20160322",
      "report_date": "20151230",
      "code_info": "Batches: Exp 05/16:   4GE1457;  4GE1500;  4GE1819;  4GE1893;     4HE1255;  4HE1396;   4HE1620;   4HE1656;   4HE1811;     4JE1035;   4JE1212;   4JE1324;   4JE1513; and      4KE1377"
    }
  ]
}