{
  "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-0327-2019",
      "product_description": "Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5815-77.",
      "product_quantity": "129,754 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:  3063783    3063784    3063785    3064092  3064093    3064094    3070349    3070350  3070351    3070352    3070353    3070354    3079030    3079031    3079032    3079033    3080011    3080224    3081498    3081500    3087126    3088476"
    }
  ]
}