{
  "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": [
          "ANDA090483"
        ],
        "brand_name": [
          "AMLODIPINE AND VALSARTAN"
        ],
        "generic_name": [
          "AMLODIPINE AND VALSARTAN"
        ],
        "manufacturer_name": [
          "Mylan Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "0378-1721",
          "0378-1722",
          "0378-1723",
          "0378-1724"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "AMLODIPINE BESYLATE",
          "VALSARTAN"
        ],
        "rxcui": [
          "722126",
          "722131",
          "722134",
          "722137"
        ],
        "spl_id": [
          "97bfe7c1-7e4b-45a1-b045-ff48275f1488"
        ],
        "spl_set_id": [
          "aa7e7d95-520a-461c-b1b3-e588aeb6a613"
        ],
        "package_ndc": [
          "0378-1721-93",
          "0378-1722-93",
          "0378-1723-93",
          "0378-1724-93"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0303781722933",
          "0303781723930",
          "0303781721936",
          "0303781724937"
        ],
        "nui": [
          "N0000000070",
          "N0000175561"
        ],
        "pharm_class_moa": [
          "Angiotensin 2 Receptor Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "Angiotensin 2 Receptor Blocker [EPC]"
        ],
        "unii": [
          "864V2Q084H",
          "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-0312-2019",
      "product_description": "Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1722-93.",
      "product_quantity": "12,336 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 # 3079500, exp. date 1/2020"
    }
  ]
}