{
  "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": "East Windsor",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA206512"
        ],
        "brand_name": [
          "AMLODIPINE AND VALSARTAN"
        ],
        "generic_name": [
          "AMLODIPINE AND VALSARTAN"
        ],
        "manufacturer_name": [
          "Aurobindo Pharma Limited"
        ],
        "product_ndc": [
          "65862-737",
          "65862-739",
          "65862-738",
          "65862-740"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "AMLODIPINE BESYLATE",
          "VALSARTAN"
        ],
        "rxcui": [
          "722126",
          "722131",
          "722134",
          "722137"
        ],
        "spl_id": [
          "909d72a6-7116-407e-8ec8-77b9b5798237"
        ],
        "spl_set_id": [
          "7fa25f10-29e0-4162-81a8-9d2e03054ded"
        ],
        "package_ndc": [
          "65862-737-30",
          "65862-737-90",
          "65862-737-10",
          "65862-737-03",
          "65862-739-30",
          "65862-739-90",
          "65862-739-10",
          "65862-739-03",
          "65862-738-30",
          "65862-738-90",
          "65862-738-10",
          "65862-738-03",
          "65862-740-30",
          "65862-740-90",
          "65862-740-10",
          "65862-740-03"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0365862739308",
          "0365862737304"
        ],
        "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": "82114",
      "recalling_firm": "Aurobindo Pharma USA Inc.",
      "address_1": "279 Princeton Hightstown Rd",
      "address_2": "N/A",
      "postal_code": "08520-1401",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed to major distribution chains throughout the United States.",
      "recall_number": "D-1036-2019",
      "product_description": "Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by: Aurobindo Pharma Limited, India --- NDC 65862-739-30",
      "product_quantity": "N/A",
      "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": "20181231",
      "center_classification_date": "20190321",
      "report_date": "20190327",
      "code_info": "Lot Numbers:  VFSA17007-A, exp. date  Oct-2019"
    }
  ]
}