{
  "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": "Horsham",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA088487"
        ],
        "brand_name": [
          "HYDROXYZINE PAMOATE"
        ],
        "generic_name": [
          "HYDROXYZINE PAMOATE"
        ],
        "manufacturer_name": [
          "Teva Pharmaceuticals USA, Inc."
        ],
        "product_ndc": [
          "0555-0302",
          "0555-0323",
          "0555-0324"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "HYDROXYZINE PAMOATE"
        ],
        "rxcui": [
          "995232",
          "995253",
          "995278"
        ],
        "spl_id": [
          "c307ca43-d41f-401b-bd15-0c753eca86e5"
        ],
        "spl_set_id": [
          "06068fff-2e79-4721-bcc7-b0938aa20e7a"
        ],
        "package_ndc": [
          "0555-0323-02",
          "0555-0323-04",
          "0555-0302-02",
          "0555-0302-04",
          "0555-0324-02"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0305550302025",
          "0305550323020"
        ],
        "unii": [
          "M20215MUFR"
        ]
      },
      "product_type": "Drugs",
      "event_id": "67412",
      "recalling_firm": "Teva Pharmaceuticals USA",
      "address_1": "425 Privet Rd",
      "address_2": "",
      "postal_code": "19044-1220",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide.",
      "recall_number": "D-1095-2014",
      "product_description": "Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0323-02.",
      "product_quantity": "35746 capsules",
      "reason_for_recall": "CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.",
      "recall_initiation_date": "20140124",
      "center_classification_date": "20140228",
      "termination_date": "20141008",
      "report_date": "20140312",
      "code_info": "Lot #  34016752A, Exp. 09/16.   Lot #  34016753A, Exp. 09/16.",
      "more_code_info": ""
    }
  ]
}