{
  "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": "Bridgewater",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA019221"
        ],
        "brand_name": [
          "VASERETIC"
        ],
        "generic_name": [
          "ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE"
        ],
        "manufacturer_name": [
          "Bausch Health US, LLC"
        ],
        "product_ndc": [
          "0187-0146"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ENALAPRIL MALEATE",
          "HYDROCHLOROTHIAZIDE"
        ],
        "rxcui": [
          "858828",
          "858830"
        ],
        "spl_id": [
          "b97cbaf1-3abe-4f23-b2a0-4ff43f8bf5cb"
        ],
        "spl_set_id": [
          "bf3007e2-8fcc-48de-8fd5-55e95033d62f"
        ],
        "package_ndc": [
          "0187-0146-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0301870146011"
        ],
        "nui": [
          "N0000175359",
          "N0000175419",
          "M0471776"
        ],
        "pharm_class_pe": [
          "Increased Diuresis [PE]"
        ],
        "pharm_class_epc": [
          "Thiazide Diuretic [EPC]"
        ],
        "pharm_class_cs": [
          "Thiazides [CS]"
        ],
        "unii": [
          "9O25354EPJ",
          "0J48LPH2TH"
        ]
      },
      "product_type": "Drugs",
      "event_id": "68572",
      "recalling_firm": "Valeant Pharmaceuticals North America LLC",
      "address_1": "400 Somerset Corporate Blvd",
      "address_2": "N/A",
      "postal_code": "08807",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0018-2015",
      "product_description": "Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles  manufactured at Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada",
      "product_quantity": "205,853 bottles",
      "reason_for_recall": "Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset",
      "recall_initiation_date": "20140521",
      "center_classification_date": "20141010",
      "termination_date": "20150804",
      "report_date": "20141022",
      "code_info": "VASERETIC 10-25MG TAB 100CT  Lot # 12J022P  exp. 9/30/2014  VASERETIC 10-25MG TAB 100CT Lot # 13G047P   exp. 07/31/2015"
    }
  ]
}