{
  "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": "Terminated",
      "city": "Newtown",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA040786"
        ],
        "brand_name": [
          "HYDROXYZINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "HYDROXYZINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "KVK-Tech, Inc."
        ],
        "product_ndc": [
          "10702-010",
          "10702-011",
          "10702-012"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "HYDROXYZINE DIHYDROCHLORIDE"
        ],
        "rxcui": [
          "995218",
          "995258",
          "995281"
        ],
        "spl_id": [
          "eff46bea-a884-5878-e053-2a95a90ae664"
        ],
        "spl_set_id": [
          "adc4cb73-77c6-48ff-aaf2-b3568d53de1f"
        ],
        "package_ndc": [
          "10702-010-01",
          "10702-010-50",
          "10702-010-10",
          "10702-011-01",
          "10702-011-50",
          "10702-011-10",
          "10702-012-01",
          "10702-012-50",
          "10702-012-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0310702012103"
        ],
        "unii": [
          "76755771U3"
        ]
      },
      "product_type": "Drugs",
      "event_id": "67103",
      "recalling_firm": "KVK-Tech, Inc.",
      "address_1": "110 Terry Dr",
      "address_2": "Suite 200",
      "postal_code": "18940-3427",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.",
      "recall_number": "D-1032-2014",
      "product_description": "HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC,  Newtown, PA 18940.  100 count NDC: 10702-012-01, 500 count NDC: 10702-012-50, 1000 count NDC: 10702-012-10.",
      "product_quantity": "104551 bottles",
      "reason_for_recall": "Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.",
      "recall_initiation_date": "20131211",
      "center_classification_date": "20140122",
      "termination_date": "20150803",
      "report_date": "20140129",
      "code_info": "NDC 10702-012-01: lot # 10667, Jan-14; lot # 10677, exp. Jan-14; lot # 10679, exp. Jan-14; lot# 10688, exp. May-14; lot #10693, exp. Jul-14; lot #10854, Jul-14; lot # 10942, exp. Sep-14; lot #10995, exp.Oct-14; lot # 10996, Nov-14; lot #11138, exp. Feb-15;  lot # 11139 Feb-15; lot # 11140, exp. Feb-15; lot # 11445, exp. Nov-15.    NDC: 10702-012-10: lot # 10679, exp. Jan-14;  lot # 10689, exp. Jun-14; lot # 10941, Sep-14; lot #10997; Nov-14; lot #10998, Nov-14; lot # 10999,  Nov-14; lot #11445, exp. Nov-15.    NDC: 10702-012-50: lot #10678, exp. Jan-14; lot #10689, exp. Jun-14;  lot #10855, exp. Jul-14; lot # 10943, exp. Sep-14; lot # 11136, exp. Feb-15;  lot #11137, exp. Feb-15; lot# 11445, exp. Nov-15.",
      "more_code_info": ""
    }
  ]
}