{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Allegan",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076447"
        ],
        "brand_name": [
          "CAREONE ALLERGY RELIEF"
        ],
        "generic_name": [
          "FEXOFENADINE HCL"
        ],
        "manufacturer_name": [
          "American Sales Company"
        ],
        "product_ndc": [
          "41520-229"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FEXOFENADINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "997420"
        ],
        "spl_id": [
          "57501f04-ba3d-4e21-af64-60674a4c9256"
        ],
        "spl_set_id": [
          "65720e72-c20d-4363-92ab-76596e043bc0"
        ],
        "package_ndc": [
          "41520-229-95",
          "41520-229-39",
          "41520-229-22"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "2S068B75ZU"
        ],
        "upc": [
          "341520319846",
          "341520319839"
        ]
      },
      "product_type": "Drugs",
      "event_id": "88384",
      "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 in the USA",
      "recall_number": "D-0334-2022",
      "product_description": "CAREONE Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine,  24HR, packaged as a)30 count bottle, NDC 41520-229-39, UPC 3 41520 31984 6;  b)45 count bottle, NDC 41520-229-95 UPC 3 41520 31983 9; Made in the Czech Republic, Distributed by: Foodhold U.S.A. LLC Landover, MD 20785. Made in Czech Republic",
      "product_quantity": "28776 containers",
      "reason_for_recall": "Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.",
      "recall_initiation_date": "20210727",
      "center_classification_date": "20220105",
      "termination_date": "20221108",
      "report_date": "20220112",
      "code_info": "Lot a) 0FR0459, Exp 2/28/2022; 0LR0362, Exp 6/30/2022; 1BR0462, Exp 10/31/2022 b) 0LR0363, Exp 6/30/2022"
    }
  ]
}