{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Philadelphia",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA201674"
        ],
        "brand_name": [
          "HYDROXYZINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "HYDROXYZINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Lannett Company, Inc."
        ],
        "product_ndc": [
          "54838-502"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "HYDROXYZINE DIHYDROCHLORIDE"
        ],
        "rxcui": [
          "995241"
        ],
        "spl_id": [
          "823645dc-4e60-4279-97fa-ca0d1c1d7ad8"
        ],
        "spl_set_id": [
          "a4fb61ae-aad6-4bd6-83fc-8b227f175df9"
        ],
        "package_ndc": [
          "54838-502-80"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0354838502800"
        ],
        "unii": [
          "76755771U3"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81225",
      "recalling_firm": "Lannett Company, Inc.",
      "address_1": "9000 State Rd",
      "address_2": "N/A",
      "postal_code": "19136-1615",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0083-2019",
      "product_description": "HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10  mg per 5 mL, Rx only, Distributed by Lannett Company, Inc., Philadelphia, PA  19154, NDC 54838-502-80.",
      "product_quantity": "8,324 bottles",
      "reason_for_recall": "CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.",
      "recall_initiation_date": "20181011",
      "center_classification_date": "20181019",
      "termination_date": "20190222",
      "report_date": "20181031",
      "code_info": "Lot #: 1097, Exp 10/18"
    }
  ]
}