{
  "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": "Morgantown",
      "state": "WV",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078020"
        ],
        "brand_name": [
          "VALSARTAN AND HYDROCHLOROTHIAZIDE"
        ],
        "generic_name": [
          "VALSARTAN AND HYDROCHLOROTHIAZIDE"
        ],
        "manufacturer_name": [
          "Mylan Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "0378-6321",
          "0378-6322",
          "0378-6323",
          "0378-6324",
          "0378-6325"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "HYDROCHLOROTHIAZIDE",
          "VALSARTAN"
        ],
        "rxcui": [
          "200284",
          "200285",
          "349353",
          "636042",
          "636045"
        ],
        "spl_id": [
          "16044239-373d-4b04-9a4d-fd4232a93b6c"
        ],
        "spl_set_id": [
          "3ba1f9f9-0037-4522-8605-e27dc8552b5b"
        ],
        "package_ndc": [
          "0378-6321-77",
          "0378-6321-05",
          "0378-6322-77",
          "0378-6322-05",
          "0378-6323-77",
          "0378-6323-05",
          "0378-6324-77",
          "0378-6324-05",
          "0378-6325-77",
          "0378-6325-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0303786323777"
        ],
        "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": "81613",
      "recalling_firm": "Mylan Pharmaceuticals Inc.",
      "address_1": "781 Chestnut Ridge Rd",
      "address_2": "N/A",
      "postal_code": "26505-2730",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Product was distributed throughout the United States.",
      "recall_number": "D-0317-2019",
      "product_description": "Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A. NDC 0378-6325-05.",
      "product_quantity": "5,660 bottles",
      "reason_for_recall": "CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.",
      "recall_initiation_date": "20181120",
      "center_classification_date": "20181214",
      "report_date": "20181219",
      "code_info": "Lot # 3084886, exp. date 2/2019     Lot # 3093804, exp. date 12/2019"
    }
  ]
}