{
  "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": "Cranbury",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "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": [
          "N0000000070",
          "N0000175561",
          "N0000175359",
          "N0000175419",
          "M0471776"
        ],
        "pharm_class_moa": [
          "Angiotensin 2 Receptor Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "Angiotensin 2 Receptor Blocker [EPC]",
          "Thiazide Diuretic [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Diuresis [PE]"
        ],
        "pharm_class_cs": [
          "Thiazides [CS]"
        ],
        "unii": [
          "J0E2756Z7N",
          "0J48LPH2TH"
        ]
      },
      "product_type": "Drugs",
      "event_id": "74423",
      "recalling_firm": "Prinston Pharmaceutical Inc",
      "address_1": "2002 Eastpark Blvd",
      "address_2": "N/A",
      "postal_code": "08512-3514",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1049-2016",
      "product_description": "Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare U.S., LLC, Cranbury, NJ  08512, NDC 43547-331-09.",
      "product_quantity": "60 bottles (5 cases)",
      "reason_for_recall": "Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.",
      "recall_initiation_date": "20160530",
      "center_classification_date": "20160623",
      "termination_date": "20170609",
      "report_date": "20160629",
      "code_info": "Lot #: 327B16002, Exp 12/17"
    }
  ]
}