{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Columbus",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA091393"
        ],
        "brand_name": [
          "OXYCODONE HYDROCHLORIDE"
        ],
        "generic_name": [
          "OXYCODONE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "American Health Packaging"
        ],
        "product_ndc": [
          "68084-354",
          "68084-968",
          "68084-975",
          "68084-983"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "OXYCODONE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1049611",
          "1049618",
          "1049621",
          "1049683"
        ],
        "spl_id": [
          "4160b55c-48e1-5cb4-e063-6294a90a1d7d"
        ],
        "spl_set_id": [
          "aa7ac2bf-d9ed-445d-b394-4d3fe39780ca"
        ],
        "package_ndc": [
          "68084-354-11",
          "68084-354-01",
          "68084-968-11",
          "68084-968-01",
          "68084-975-11",
          "68084-975-01",
          "68084-983-11",
          "68084-983-01"
        ],
        "original_packager_product_ndc": [
          "10702-018",
          "10702-056",
          "10702-008",
          "10702-009"
        ],
        "unii": [
          "C1ENJ2TE6C"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98308",
      "recalling_firm": "Amerisource Health Services LLC",
      "address_1": "2550 John Glenn Ave Ste A",
      "address_2": "N/A",
      "postal_code": "43217-1188",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0338-2026",
      "product_description": "Oxycodone Hydrochloride Tablets, USP (CII), 5 mg,  100-Count (10 x 10) blister cards per carton,  Rx Only, The drug product contained in this package is from NDC # 10702-018, KVK-Tech Inc.  Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-354-01; Blister NDC 68084-354-11",
      "product_quantity": "31,676 packages",
      "reason_for_recall": "Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.",
      "recall_initiation_date": "20260114",
      "center_classification_date": "20260213",
      "report_date": "20260218",
      "code_info": "Lots #: 1027932, Exp Date 06/30/2027, 1028360, Exp Date 08/31/2027"
    }
  ]
}