{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Houston",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "CODEINE-GUAIFENESIN"
        ],
        "generic_name": [
          "CODEINE PHOSPHATE AND GUAIFENESIN"
        ],
        "manufacturer_name": [
          "Method Pharmaceuticals, LLC"
        ],
        "product_ndc": [
          "58657-500"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CODEINE PHOSPHATE",
          "GUAIFENESIN"
        ],
        "rxcui": [
          "995868"
        ],
        "spl_id": [
          "41b41a1f-2e84-3be6-e063-6294a90a888d"
        ],
        "spl_set_id": [
          "fe126254-6ee6-48c3-965c-96e4276a5314"
        ],
        "package_ndc": [
          "58657-500-04",
          "58657-500-16"
        ],
        "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": "78757",
      "recalling_firm": "Woodfield Pharmaceutical, LLC",
      "address_1": "10863 Rockley Rd",
      "address_2": "N/A",
      "postal_code": "77099-3405",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Texas",
      "recall_number": "D-0210-2018",
      "product_description": "Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 fl. oz. , Manufactured For: Method Pharmaceuticals, LLC Arlington, TX 76006, NDC 58657-500-16",
      "product_quantity": "15,707 bottles",
      "reason_for_recall": "Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia",
      "recall_initiation_date": "20171212",
      "center_classification_date": "20180108",
      "termination_date": "20200124",
      "report_date": "20180117",
      "code_info": "Lot: 08616; Exp. 07/18",
      "more_code_info": ""
    }
  ]
}