{
  "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": "2026-08-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Mumbai",
      "state": "N/A",
      "country": "India",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA077829"
        ],
        "brand_name": [
          "CETIRIZINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "CETIRIZINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Rising Pharma Holdings, Inc."
        ],
        "product_ndc": [
          "16571-401"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CETIRIZINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1014676"
        ],
        "spl_id": [
          "37fb3dd8-d5bf-46e4-8331-0c8c1eac540d"
        ],
        "spl_set_id": [
          "6493d4f6-dead-45ec-ade1-28ce624af33d"
        ],
        "package_ndc": [
          "16571-401-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "64O047KTOA"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99321",
      "recalling_firm": "JB Chemicals and Pharmaceuticals Ltd",
      "address_1": "Neelam Centre A Wing A B Wing",
      "address_2": "4th Floor; Hind Cycle Road",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0732-2026",
      "product_description": "Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-401-10.",
      "product_quantity": "34,020 100-count bottles.",
      "reason_for_recall": "Cross Contamination with Other Products: Customer complaints for appearance of  discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.",
      "recall_initiation_date": "20260624",
      "center_classification_date": "20260803",
      "report_date": "20260729",
      "code_info": "Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT"
    }
  ]
}