{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Completed",
      "city": "East Windsor",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078450"
        ],
        "brand_name": [
          "QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE"
        ],
        "generic_name": [
          "QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE"
        ],
        "manufacturer_name": [
          "Aurobindo Pharma Limited"
        ],
        "product_ndc": [
          "65862-161",
          "65862-162",
          "65862-163"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "QUINAPRIL HYDROCHLORIDE",
          "HYDROCHLOROTHIAZIDE"
        ],
        "rxcui": [
          "310796",
          "310797",
          "310809"
        ],
        "spl_id": [
          "5842ecc2-874a-481b-8997-afa9d862dc5d"
        ],
        "spl_set_id": [
          "50a58159-9572-4445-9859-b392632597da"
        ],
        "package_ndc": [
          "65862-161-90",
          "65862-162-30",
          "65862-162-90",
          "65862-163-90"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0365862161901"
        ],
        "nui": [
          "N0000175359",
          "N0000175419",
          "M0471776"
        ],
        "pharm_class_pe": [
          "Increased Diuresis [PE]"
        ],
        "pharm_class_epc": [
          "Thiazide Diuretic [EPC]"
        ],
        "pharm_class_cs": [
          "Thiazides [CS]"
        ],
        "unii": [
          "33067B3N2M",
          "0J48LPH2TH"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90949",
      "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": "Nationwide",
      "recall_number": "D-0021-2023",
      "product_description": "Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road  East Windsor, NJ 08520, Made in India, NDC 65862-162-90",
      "product_quantity": "9504 bottles",
      "reason_for_recall": "CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.",
      "recall_initiation_date": "20221005",
      "center_classification_date": "20221026",
      "report_date": "20221102",
      "code_info": "Lots QE2021005-A and QE2021010-A, exp 01/2023",
      "more_code_info": ""
    }
  ]
}