{
  "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": "Terminated",
      "city": "Baltimore",
      "state": "MD",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077690"
        ],
        "brand_name": [
          "QUINAPRIL"
        ],
        "generic_name": [
          "QUINAPRIL"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "68180-554",
          "68180-556",
          "68180-557",
          "68180-558",
          "68180-559"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "QUINAPRIL HYDROCHLORIDE"
        ],
        "rxcui": [
          "312748",
          "312749",
          "312750",
          "314203"
        ],
        "spl_id": [
          "a9598a21-6f99-4c86-ace6-b5638da2bec8"
        ],
        "spl_set_id": [
          "8ded0773-3aec-4e89-9836-d22a5a84abf0"
        ],
        "package_ndc": [
          "68180-556-09",
          "68180-557-09",
          "68180-557-03",
          "68180-558-09",
          "68180-558-03",
          "68180-554-09",
          "68180-554-03",
          "68180-559-03",
          "68180-559-09"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368180559092",
          "0368180556091"
        ],
        "unii": [
          "33067B3N2M"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91279",
      "recalling_firm": "Lupin Pharmaceuticals Inc.",
      "address_1": "Harborplace Tower",
      "address_2": "111 S Calvert St Fl 21st",
      "postal_code": "21202-6174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed by major distribution chains nationwide.",
      "recall_number": "D-0088-2023",
      "product_description": "Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-554-09",
      "product_quantity": "30,612 bottles",
      "reason_for_recall": "CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.",
      "recall_initiation_date": "20221207",
      "center_classification_date": "20221223",
      "termination_date": "20240801",
      "report_date": "20221228",
      "code_info": "Lot #: G100533, G100534, Exp. 12/2022; G203071, Exp. 03/2024",
      "more_code_info": ""
    }
  ]
}