{
  "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": [
          "ANDA202519"
        ],
        "brand_name": [
          "VALSARTAN AND HYDROCHLOROTHIAZIDE"
        ],
        "generic_name": [
          "VALSARTAN AND HYDROCHLOROTHIAZIDE"
        ],
        "manufacturer_name": [
          "Aurobindo Pharma Limited"
        ],
        "product_ndc": [
          "65862-547",
          "65862-548",
          "65862-549",
          "65862-550",
          "65862-551"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "HYDROCHLOROTHIAZIDE",
          "VALSARTAN"
        ],
        "rxcui": [
          "200284",
          "200285",
          "349353",
          "636042",
          "636045"
        ],
        "spl_id": [
          "81a03db7-4be2-478d-b625-e59c8bd2235f"
        ],
        "spl_set_id": [
          "c5bc7c55-b50c-4e61-ad1f-5ebb607c262f"
        ],
        "package_ndc": [
          "65862-547-90",
          "65862-547-99",
          "65862-547-10",
          "65862-548-90",
          "65862-548-99",
          "65862-548-10",
          "65862-549-90",
          "65862-549-99",
          "65862-549-10",
          "65862-550-90",
          "65862-550-05",
          "65862-551-90",
          "65862-551-05"
        ],
        "is_original_packager": [
          true
        ],
        "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": "81887",
      "recalling_firm": "Aurobindo Pharma USA Inc.",
      "address_1": "279 Princeton Hightstown Rd",
      "address_2": "",
      "postal_code": "08520-1401",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.",
      "recall_number": "D-0369-2019",
      "product_description": "Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-549-90.",
      "product_quantity": "53,064 bottles",
      "reason_for_recall": "CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.",
      "recall_initiation_date": "20181231",
      "center_classification_date": "20190114",
      "report_date": "20190123",
      "code_info": "Lot # HVSB17023-A, exp. date 08/2020  Lot # HVSB17036-A, exp. date 11/2020  Lot # HVSB17037-A, exp. date 11/2020  Lot # HVSB17038-A, exp. date 11/2020  Lot # HVSB17039-A, exp. date 11/2020  Lot # HVSB17040-B, exp. date 11/2020  Lot # HVSB18001-A, exp. date 12/2020  Lot # HVSB18002-A, exp. date 12/2020  Lot # HVSB18003-A, exp. date 12/2020  Lot # HVSB18004-A, exp. date 12/2020",
      "more_code_info": ""
    }
  ]
}