{
  "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": [
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        "spl_set_id": [
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        "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-1296-2014",
      "product_description": "Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83",
      "product_quantity": "128,363 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": "JKM2067A Exp. 07/14, JKM2068A Exp.10/14, JKM2069A Exp. 01/15, JKM6399A Exp. 04/15",
      "more_code_info": ""
    }
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}