{
  "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": "Completed",
      "city": "Somerset",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA203072"
        ],
        "brand_name": [
          "IRBESARTAN AND HYDROCHLOROTHIAZIDE"
        ],
        "generic_name": [
          "IRBESARTAN AND HYDROCHLOROTHIAZIDE"
        ],
        "manufacturer_name": [
          "Solco Healthcare US, LLC"
        ],
        "product_ndc": [
          "43547-330",
          "43547-331"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "HYDROCHLOROTHIAZIDE",
          "IRBESARTAN"
        ],
        "rxcui": [
          "310792",
          "310793"
        ],
        "spl_id": [
          "3e6f512c-8ff3-40b0-bcd3-9bf9bf26a112"
        ],
        "spl_set_id": [
          "72fa8cd4-bc2a-4a7d-8feb-2d60e077d801"
        ],
        "package_ndc": [
          "43547-330-03",
          "43547-330-09",
          "43547-330-50",
          "43547-331-03",
          "43547-331-09",
          "43547-331-50"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0343547331030",
          "0343547330033"
        ],
        "nui": [
          "N0000175359",
          "N0000175419",
          "M0471776",
          "N0000000070",
          "N0000175561"
        ],
        "pharm_class_pe": [
          "Increased Diuresis [PE]"
        ],
        "pharm_class_epc": [
          "Thiazide Diuretic [EPC]",
          "Angiotensin 2 Receptor Blocker [EPC]"
        ],
        "pharm_class_cs": [
          "Thiazides [CS]"
        ],
        "pharm_class_moa": [
          "Angiotensin 2 Receptor Antagonists [MoA]"
        ],
        "unii": [
          "0J48LPH2TH",
          "J0E2756Z7N"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81910",
      "recalling_firm": "Prinston Pharmaceutical Inc",
      "address_1": "700 Atrium Dr",
      "address_2": "N/A",
      "postal_code": "08873-4107",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0412-2019",
      "product_description": "Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China   Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512  90 count  NDC 43547-331-09",
      "product_quantity": "12294 bottles",
      "reason_for_recall": "CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.",
      "recall_initiation_date": "20190118",
      "center_classification_date": "20190127",
      "report_date": "20190206",
      "code_info": "327B18008  327B18009"
    }
  ]
}