{
  "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": "Sinnar, Nashik District",
      "state": "N/A",
      "country": "India",
      "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": "81707",
      "recalling_firm": "Mylan Laboratories Limited, (Nashik FDF)",
      "address_1": "F-4 F-12, Malegaon M.I.D.C., Sinnar",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Product was distributed throughout the United States to several major distributors, including Puerto Rico.",
      "recall_number": "D-0329-2019",
      "product_description": "Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), (b) 500-count bottles (NDC 0378-6322-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.",
      "product_quantity": "50,595 HDPE bottles",
      "reason_for_recall": "GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.",
      "recall_initiation_date": "20181204",
      "center_classification_date": "20181214",
      "report_date": "20181219",
      "code_info": "Lot numbers:  2008880    3084358    3084359    3093801    3084359    3084361    3093801"
    }
  ]
}