{
  "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": [
          "ANDA090866"
        ],
        "brand_name": [
          "VALSARTAN"
        ],
        "generic_name": [
          "VALSARTAN"
        ],
        "manufacturer_name": [
          "Mylan Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "0378-5807",
          "0378-5813",
          "0378-5814",
          "0378-5815"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "VALSARTAN"
        ],
        "rxcui": [
          "349199",
          "349200",
          "349201",
          "349483"
        ],
        "spl_id": [
          "a5384d58-48c7-494a-a8a8-c296b316bd91"
        ],
        "spl_set_id": [
          "73e01dc6-7dd4-421a-a4f6-137e75f69f9a"
        ],
        "package_ndc": [
          "0378-5807-93",
          "0378-5813-77",
          "0378-5814-77",
          "0378-5815-77"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0303785815778",
          "0303785813774",
          "0303785807933",
          "0303785814771"
        ],
        "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": "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-0325-2019",
      "product_description": "Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5813-77.",
      "product_quantity": "119,761 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: 3065445, 3074880, 3074883, 3086688, 3086689, 3086710"
    }
  ]
}