{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Hawthorne",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA201546"
        ],
        "brand_name": [
          "CHILDRENS ALLERGY"
        ],
        "generic_name": [
          "CETIRIZINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Publix Super Markets Inc"
        ],
        "product_ndc": [
          "56062-106"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CETIRIZINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1014673"
        ],
        "spl_id": [
          "29a2f347-2061-7d9a-e063-6294a90a98e9"
        ],
        "spl_set_id": [
          "9a8b5af0-72bb-48d5-bb5e-0dc6808bf466"
        ],
        "package_ndc": [
          "56062-106-08"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0041415435735",
          "041415435735"
        ],
        "unii": [
          "64O047KTOA"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81483",
      "recalling_firm": "Taro Pharmaceuticals U.S.A., Inc.",
      "address_1": "3 Skyline Dr",
      "address_2": "",
      "postal_code": "10532-2174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0277-2019",
      "product_description": "children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120 mL) bottle, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, NDC 56062-106-08, UPC 0 41415 43573 5.",
      "product_quantity": "8328 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.",
      "recall_initiation_date": "20181019",
      "center_classification_date": "20181120",
      "termination_date": "20201103",
      "report_date": "20181121",
      "code_info": "Lot # 313345, Exp 12/18",
      "more_code_info": ""
    }
  ]
}