{
  "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": "Cranbury",
      "state": "NJ",
      "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": "77103",
      "recalling_firm": "Sun Pharmaceutical Industries, Inc.",
      "address_1": "270 Prospect Plains Rd",
      "address_2": "",
      "postal_code": "08512-3605",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA and Puerto Rico",
      "recall_number": "D-0857-2017",
      "product_description": "Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol - 389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ  08512, NDC 47335-343-83.",
      "product_quantity": "13,200 bottles",
      "reason_for_recall": "Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.",
      "recall_initiation_date": "20170418",
      "center_classification_date": "20170523",
      "termination_date": "20180518",
      "report_date": "20170531",
      "code_info": "Lot #: JKR5135A, Exp 11/17",
      "more_code_info": ""
    }
  ]
}