{
  "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": [
          "ANDA203071"
        ],
        "brand_name": [
          "IRBESARTAN"
        ],
        "generic_name": [
          "IRBESARTAN"
        ],
        "manufacturer_name": [
          "Solco Healthcare U.S., LLC"
        ],
        "product_ndc": [
          "43547-374",
          "43547-375",
          "43547-376"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "IRBESARTAN"
        ],
        "rxcui": [
          "200094",
          "200095",
          "200096"
        ],
        "spl_id": [
          "9dd3ba36-25b6-45da-906f-316049b9f23b"
        ],
        "spl_set_id": [
          "6916c617-92d2-44f5-b968-6267517a2ce6"
        ],
        "package_ndc": [
          "43547-374-03",
          "43547-374-09",
          "43547-374-50",
          "43547-375-03",
          "43547-375-09",
          "43547-375-50",
          "43547-376-03",
          "43547-376-09",
          "43547-376-50"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000000070",
          "N0000175561"
        ],
        "pharm_class_moa": [
          "Angiotensin 2 Receptor Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "Angiotensin 2 Receptor Blocker [EPC]"
        ],
        "unii": [
          "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-0409-2019",
      "product_description": "Irbesartan Tablets 300 mg 90 count  Rx only    Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang  317024 China     Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512   NDC 43547-376-09",
      "product_quantity": "19800 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": "331B18009"
    }
  ]
}