{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Alpharetta",
      "state": "GA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA018965"
        ],
        "brand_name": [
          "NAPROXEN"
        ],
        "generic_name": [
          "NAPROXEN"
        ],
        "manufacturer_name": [
          "Acella Pharmaceuticals, LLC"
        ],
        "product_ndc": [
          "42192-619"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "NAPROXEN"
        ],
        "rxcui": [
          "311913"
        ],
        "spl_id": [
          "47a98b71-a338-b13d-e063-6394a90a96f6"
        ],
        "spl_set_id": [
          "7e6f03fb-4b36-4418-9684-f45637abbb78"
        ],
        "package_ndc": [
          "42192-619-16"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0342192619166"
        ],
        "nui": [
          "N0000000160",
          "M0001335",
          "N0000175722"
        ],
        "pharm_class_moa": [
          "Cyclooxygenase Inhibitors [MoA]"
        ],
        "pharm_class_cs": [
          "Anti-Inflammatory Agents, Non-Steroidal [CS]"
        ],
        "pharm_class_epc": [
          "Nonsteroidal Anti-inflammatory Drug [EPC]"
        ],
        "unii": [
          "57Y76R9ATQ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98781",
      "recalling_firm": "Acella Pharmaceuticals, LLC",
      "address_1": "1880 Mcfarland Pkwy Ste 110",
      "address_2": "",
      "postal_code": "30005-1795",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0523-2026",
      "product_description": "NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada  NDC 42192-619-16",
      "product_quantity": "6,336 bottles",
      "reason_for_recall": "Chemical contamination; presence of lead and lithium above specification",
      "recall_initiation_date": "20260420",
      "center_classification_date": "20260506",
      "report_date": "20260513",
      "code_info": "Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.",
      "more_code_info": ""
    }
  ]
}