{
  "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": [
          "NDA018998"
        ],
        "brand_name": [
          "VASOTEC"
        ],
        "generic_name": [
          "ENALAPRIL MALEATE"
        ],
        "manufacturer_name": [
          "Bausch Health US LLC"
        ],
        "product_ndc": [
          "0187-0140",
          "0187-0141",
          "0187-0142",
          "0187-0143"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ENALAPRIL MALEATE"
        ],
        "rxcui": [
          "858804",
          "858806",
          "858810",
          "858812",
          "858813",
          "858815",
          "858817",
          "858819"
        ],
        "spl_id": [
          "1be6ec2b-1c20-4ff4-a8ff-cd23e3de9fa4"
        ],
        "spl_set_id": [
          "39631f1f-5d19-43c1-b504-bf56d991ed97"
        ],
        "package_ndc": [
          "0187-0140-30",
          "0187-0140-90",
          "0187-0141-30",
          "0187-0141-90",
          "0187-0141-10",
          "0187-0142-30",
          "0187-0142-90",
          "0187-0142-10",
          "0187-0143-30",
          "0187-0143-90",
          "0187-0143-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0301870143300"
        ],
        "unii": [
          "9O25354EPJ"
        ]
      },
      "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-0019-2015",
      "product_description": "Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada    2.5 mg  90 ct -  NDC 0187-0140-90    5 mg 30 ct - NDC  0187-0141-30    5 mg 90 ct - NDC 0187-0141-90    10 mg 30 ct - NDC 0187-0142-30    10 mg 90 ct - NDC 0187-0142-90    10 mg  1000 ct - NDC 0187-0142-10      20 mg 30 ct - NDC 0187-0143-30    20 mg 90 ct - NDC 0187-0143-90     20 mg 1000 ct - NDC 0187-0143-10          NDC #'s 64455-140, 64455-141, 64455-142 and 64455-143, 30 ct. bottles, 90 ct. bottles and 1000 ct. bottles",
      "product_quantity": "205,853 bottles",
      "reason_for_recall": "Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.",
      "recall_initiation_date": "20140521",
      "center_classification_date": "20141010",
      "termination_date": "20150804",
      "report_date": "20141022",
      "code_info": "VASOTEC 2.5MG TAB 30CT  12K015P  exp.  9/30/2014      VASOTEC 2.5MG TAB 30CT  13G048P   exp.  07/31/2015    VASOTEC 2.5MG TAB 30CT  14A065P   exp. 07/31/2015    VASOTEC 2.5MG TAB 90CT  13G020P   exp. 07/31/2015      VASOTEC 2.5MG TAB 90CT   12K020P  exp.  9/30/2014      VASOTEC 2.5MG TAB 90CT  13B016P   exp. 9/30/2014      VASOTEC 5MG TAB 30CT   13B022P   exp. 2/28/2015    VASOTEC 5MG TAB 30CT 13B023P   exp. 2/28/2015    VASOTEC 5MG TAB 30CT  13C015P   exp. 02/28/2015    VASOTEC 5MG TAB 30CT  13E002P   exp. 02/28/2015    VASOTEC 5MG TAB 30CT 14A002P   exp.    11/30/2015    VASOTEC 5MG TAB 30CT  13L066P   exp. 11/30/2015    VASOTEC 5MG TAB 90CT   13B018P   exp. 2/28/2015      VASOTEC 5MG TAB 90CT  13G015P   exp. 06/30/2015      VASOTEC 10MG TAB 90CT   12M017P   exp. 11/30/2014    VASOTEC 10MG TAB 1000CT   12L105P   exp. 11/30/2014      VASOTEC 10MG TAB 30CT   12M016P   exp. 11/30/2014      VASOTEC 10MG TAB 30CT  13G013P   exp. 06/30/2015    VASOTEC 10MG TAB 30CT  13J081P  exp. 9/30/2015    VASOTEC 10MG TAB 90CT 12M025P   exp. 11/30/2014    VASOTEC 10MG TAB 90CT  13J082P   exp. 0/2015    VASOTEC 10MG TAB 90CT  13J085P   exp. 0/2015    VASOTEC 10MG TAB 90CT  13J094P   exp. 09/30/2015    VASOTEC 10MG TAB 1000CT  13J098P   exp. 09/30/2015    VASOTEC 10MG TAB 1000CT  13G011P   exp. 06/30/2015    VASOTEC 10MG TAB 1000CT  13J097P   exp. 09/30/2015    VASOTEC 20MG TAB 30CT   12J017P   exp. 5/31/2014    VASOTEC 20MG TAB 30CT   13C016P   exp. 2/28/2015    VASOTEC 20MG TAB 30CT  13E003P   exp. 02/28/2015    VASOTEC 20MG TAB 30CT  13L068P   exp. 09/30/2015    VASOTEC 20MG TAB 90CT  13J086P   exp. 09/30/2015    VASOTEC 20MG TAB 90CT  13J087P   exp. 09/30/2015      VASOTEC 20MG TAB 90CT   12M029P   exp. 11/30/2014    VASOTEC 20MG TAB 90CT   12M030P   exp. 11/30/2014    VASOTEC 20MG TAB 1000CT   12J023P   exp. 5/31/2014    VASOTEC 20MG TAB 1000CT  12L108P   exp. 11/30/2014    VASOTEC 20MG TAB 1000CT  13C088P   exp. 02/28/2015    VASOTEC 20MG TAB 1000CT  13J099P   exp. 09/30/2015    VASOTEC 20MG TAB 1000CT  13M054P   exp. 09/30/2015    VASOTEC 20MG TAB 1000CT  13M055P   exp. 12/31/2015    VASOTEC 20MG TAB 1000CT  14B054P   exp. 12/31/2015"
    }
  ]
}