{
  "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": "2026-07-01",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Baudette",
      "state": "MN",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA219648"
        ],
        "brand_name": [
          "HYDROXYZINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "HYDROXYZINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "ANI Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "70954-912"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "HYDROXYZINE DIHYDROCHLORIDE"
        ],
        "rxcui": [
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        "spl_id": [
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        ],
        "spl_set_id": [
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        "package_ndc": [
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        ],
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        "upc": [
          "0370954912101"
        ],
        "unii": [
          "76755771U3"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99131",
      "recalling_firm": "ANI Pharmaceuticals, Inc.",
      "address_1": "210 W Main St",
      "address_2": "N/A",
      "postal_code": "56623-2467",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0619-2026",
      "product_description": "hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623.  NDC: 70954-912-10",
      "product_quantity": "6564 bottles",
      "reason_for_recall": "Presence of foreign substance",
      "recall_initiation_date": "20260602",
      "center_classification_date": "20260624",
      "report_date": "20260701",
      "code_info": "Lot S25133A"
    }
  ]
}