{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Completed",
      "city": "Greenville",
      "state": "SC",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "GUAIFENESIN AND CODEINE PHOSPHATE"
        ],
        "generic_name": [
          "GUAIFENESIN AND CODEINE PHOSPHATE"
        ],
        "manufacturer_name": [
          "PAI Holdings, LLC"
        ],
        "product_ndc": [
          "0121-0775",
          "0121-1775",
          "0121-1550"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CODEINE PHOSPHATE",
          "GUAIFENESIN"
        ],
        "rxcui": [
          "995868"
        ],
        "spl_id": [
          "2175415b-f07e-50a6-e063-6394a90acabe"
        ],
        "spl_set_id": [
          "88d0994c-4270-4408-8837-bd97510b2118"
        ],
        "package_ndc": [
          "0121-0775-04",
          "0121-0775-08",
          "0121-0775-16",
          "0121-1775-05",
          "0121-1775-00",
          "0121-1775-10",
          "0121-1775-40",
          "0121-1550-10",
          "0121-1550-00",
          "0121-1550-40"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000193956",
          "N0000008867",
          "N0000009560"
        ],
        "pharm_class_epc": [
          "Expectorant [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Respiratory Secretion Viscosity [PE]",
          "Increased Respiratory Secretions [PE]"
        ],
        "unii": [
          "GSL05Y1MN6",
          "495W7451VQ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96119",
      "recalling_firm": "PAI Holdings, LLC. dba Pharmaceutical Associates Inc",
      "address_1": "1700 Perimeter Rd",
      "address_2": "",
      "postal_code": "29605-5252",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "OH",
      "recall_number": "D-0222-2025",
      "product_description": "Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-0775-16",
      "product_quantity": "4080 Bottles",
      "reason_for_recall": "Superpotent; sodium benzoate preservative",
      "recall_initiation_date": "20250107",
      "center_classification_date": "20250204",
      "report_date": "20250212",
      "code_info": "Lot number 4B07, Exp Date: 2026-OCT-31",
      "more_code_info": ""
    }
  ]
}