{
  "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": "Terminated",
      "city": "Cranbury",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA204821"
        ],
        "brand_name": [
          "VALSARTAN"
        ],
        "generic_name": [
          "VALSARTAN"
        ],
        "manufacturer_name": [
          "Solco Healthcare US, LLC"
        ],
        "product_ndc": [
          "43547-367",
          "43547-368",
          "43547-369",
          "43547-370"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "VALSARTAN"
        ],
        "rxcui": [
          "349199",
          "349200",
          "349201",
          "349483"
        ],
        "spl_id": [
          "c540c941-b8fc-4a32-bfa7-00fba4ca9dcf"
        ],
        "spl_set_id": [
          "26080940-bcd3-446d-9026-3ddfb58e281e"
        ],
        "package_ndc": [
          "43547-367-03",
          "43547-367-09",
          "43547-367-50",
          "43547-367-11",
          "43547-368-03",
          "43547-368-09",
          "43547-368-50",
          "43547-368-11",
          "43547-369-03",
          "43547-369-09",
          "43547-369-50",
          "43547-369-11",
          "43547-370-03",
          "43547-370-09",
          "43547-370-50",
          "43547-370-11"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0343547370039",
          "0343547369033",
          "0343547368036",
          "0343547367039"
        ],
        "nui": [
          "N0000000070",
          "N0000175561"
        ],
        "pharm_class_moa": [
          "Angiotensin 2 Receptor Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "Angiotensin 2 Receptor Blocker [EPC]"
        ],
        "unii": [
          "80M03YXJ7I"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78651",
      "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 in the USA and Puerto Rico",
      "recall_number": "D-0209-2018",
      "product_description": "Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare US, LLC, Cranbury, NJ 08512, USA; NDC 43547-369-09.",
      "product_quantity": "21,987 bottles",
      "reason_for_recall": "Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.",
      "recall_initiation_date": "20171129",
      "center_classification_date": "20180108",
      "termination_date": "20190816",
      "report_date": "20180117",
      "code_info": "Lot #: 343B17025, Exp 03/31/19",
      "more_code_info": ""
    }
  ]
}