{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Mumbai",
      "state": "",
      "country": "India",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA077829"
        ],
        "brand_name": [
          "CETIRIZINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "CETIRIZINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Rising Pharma Holdings, Inc."
        ],
        "product_ndc": [
          "16571-402"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CETIRIZINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1014678"
        ],
        "spl_id": [
          "538948d8-34aa-4460-8d66-ee8fcf4c60ab"
        ],
        "spl_set_id": [
          "5481ccb3-b311-4b25-b923-4fe8522ea92b"
        ],
        "package_ndc": [
          "16571-402-10",
          "16571-402-30",
          "16571-402-50"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "64O047KTOA"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97573",
      "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": "U.S. Nationwide",
      "recall_number": "D-0033-2026",
      "product_description": "Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, 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 16571-402-50",
      "product_quantity": "13,440 bottles",
      "reason_for_recall": "Tablet/Capsules Imprinted with Wrong ID",
      "recall_initiation_date": "20250912",
      "center_classification_date": "20251017",
      "report_date": "20251029",
      "code_info": "Lot # PY925014, PY925013, Exp. 1/31/2028",
      "more_code_info": ""
    }
  ]
}