{
  "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": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Columbus",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA208339"
        ],
        "brand_name": [
          "ABIRTEGA"
        ],
        "generic_name": [
          "ABIRATERONE ACETATE"
        ],
        "manufacturer_name": [
          "CivicaScript, LLC"
        ],
        "product_ndc": [
          "82249-011"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ABIRATERONE ACETATE"
        ],
        "rxcui": [
          "1100075",
          "2702601"
        ],
        "spl_id": [
          "692d596d-5465-4611-82f7-5d50c37270a2"
        ],
        "spl_set_id": [
          "2f932015-28b2-4f44-ac04-772e982e13e9"
        ],
        "package_ndc": [
          "82249-011-12"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0382249011123"
        ],
        "unii": [
          "EM5OCB9YJ6"
        ]
      },
      "product_type": "Drugs",
      "event_id": "100046",
      "recalling_firm": "Hikma Pharmaceuticals USA INC.",
      "address_1": "1809 Wilson Rd",
      "address_2": "",
      "postal_code": "43228-9579",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0076-2027",
      "product_description": "Abirtega (abiraterone acetate) USP, 250 mg, 120-count bottles, Rx only, Rx only, Mfd for: Hikma Pharmaceuticals USA Inc., Berkley Heights, NJ 07922 USA by: Arab Pharmaceuticals Manufacturing PSC PO Box 41, Sahab-Jordon, NDC 82249-011-12.",
      "product_quantity": "2136 bottles",
      "reason_for_recall": "Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.",
      "recall_initiation_date": "20261006",
      "center_classification_date": "20261023",
      "report_date": "20261028",
      "code_info": "Lot #: 3047, Exp Date July 2027.",
      "more_code_info": ""
    }
  ]
}