{
  "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": "Ongoing",
      "city": "Cranbury",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA206083"
        ],
        "brand_name": [
          "VALSARTAN AND HYDROCHLOROTHIAZIDE"
        ],
        "generic_name": [
          "VALSARTAN AND HYDROCHLOROTHIAZIDE"
        ],
        "manufacturer_name": [
          "Solco Healthcare US, LLC"
        ],
        "product_ndc": [
          "43547-311",
          "43547-312",
          "43547-313",
          "43547-314",
          "43547-315"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "HYDROCHLOROTHIAZIDE",
          "VALSARTAN"
        ],
        "spl_id": [
          "2d03a607-2ffd-4df1-8c94-bec2b786709c"
        ],
        "spl_set_id": [
          "f8b0a8ab-4549-4553-a127-bf2c0291a4b1"
        ],
        "package_ndc": [
          "43547-311-03",
          "43547-311-09",
          "43547-311-50",
          "43547-312-03",
          "43547-312-09",
          "43547-312-50",
          "43547-313-03",
          "43547-313-09",
          "43547-313-50",
          "43547-314-03",
          "43547-314-09",
          "43547-314-50",
          "43547-315-03",
          "43547-315-09",
          "43547-315-50"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0343547315092",
          "0343547314095",
          "0343547313036",
          "0343547315030",
          "0343547312091",
          "0343547311032",
          "0343547314033",
          "0343547312039",
          "0343547311094",
          "0343547313098"
        ],
        "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",
          "80M03YXJ7I"
        ]
      },
      "product_type": "Drugs",
      "event_id": "80525",
      "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": "United States",
      "recall_number": "D-0976-2018",
      "product_description": "Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd.  Xynqiao, Linhai, Zhejiang 317024, China  Distributed by:  Solco Healthcare US, LLC  Cranbury, NJ 08512 USA   NDC 43547-315-09",
      "product_quantity": "N/A",
      "reason_for_recall": "CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.",
      "recall_initiation_date": "20180713",
      "center_classification_date": "20180720",
      "report_date": "20180801",
      "code_info": "All lots within expiry."
    }
  ]
}