{
  "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": "Detroit",
      "state": "MI",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA090142"
        ],
        "brand_name": [
          "CETIRIZINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "CETIRIZINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "47335-343",
          "47335-344"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CETIRIZINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1014643",
          "1014674"
        ],
        "spl_id": [
          "2ffbb45f-ed2b-4f1a-bc4c-1e8c1ddcbfd3"
        ],
        "spl_set_id": [
          "a4758152-97dd-4a27-b4d9-11178654b93e"
        ],
        "package_ndc": [
          "47335-343-83",
          "47335-343-88",
          "47335-344-83",
          "47335-344-88"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0347335344837",
          "0347335343830"
        ],
        "unii": [
          "64O047KTOA"
        ]
      },
      "product_type": "Drugs",
      "event_id": "67971",
      "recalling_firm": "Caraco Pharmaceutical Laboratories, Ltd.",
      "address_1": "1150 Elijah McCoy Dr",
      "address_2": "",
      "postal_code": "48202-3344",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1297-2014",
      "product_description": "Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg,  30 count bottle, OTC,  Manufactured by Sun Pharma, Gujarat, India, Distributed Chain Drug Consortium, Boca Raton, FL,  NDC 47335-344-83",
      "product_quantity": "47,813 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide",
      "recall_initiation_date": "20140409",
      "center_classification_date": "20140501",
      "termination_date": "20141007",
      "report_date": "20140507",
      "code_info": "JKM2070A  Exp. 07/14, JKM2071A Exp.10/14, JKM2072A Exp. 01/15, JKM2072B Exp. 01/15, JKM6400A Exp. 04/15",
      "more_code_info": ""
    }
  ]
}