{
  "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": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA021620"
        ],
        "brand_name": [
          "MUCINEX DM"
        ],
        "generic_name": [
          "GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE"
        ],
        "manufacturer_name": [
          "RB Health (US) LLC"
        ],
        "product_ndc": [
          "63824-056"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DEXTROMETHORPHAN HYDROBROMIDE",
          "GUAIFENESIN"
        ],
        "rxcui": [
          "1298324"
        ],
        "spl_id": [
          "324ae895-9603-57d1-e063-6394a90aaf45"
        ],
        "spl_set_id": [
          "70987d06-d206-445f-bd0d-5e1345b8465c"
        ],
        "package_ndc": [
          "63824-056-89",
          "63824-056-36",
          "63824-056-32",
          "63824-056-34",
          "63824-056-69",
          "63824-056-73",
          "63824-056-74",
          "63824-056-72",
          "63824-056-11",
          "63824-056-01",
          "63824-056-50",
          "63824-056-80"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363824056203"
        ],
        "nui": [
          "N0000193956",
          "N0000008867",
          "N0000009560"
        ],
        "pharm_class_epc": [
          "Expectorant [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Respiratory Secretion Viscosity [PE]",
          "Increased Respiratory Secretions [PE]"
        ],
        "unii": [
          "9D2RTI9KYH",
          "495W7451VQ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "70840",
      "recalling_firm": "Reckitt Benckiser LLC",
      "address_1": "399 Interpace Pkwy",
      "address_2": "",
      "postal_code": "07054-1133",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0964-2015",
      "product_description": "Mucinex DM (guaifenesin 600mg and dextromethorphan HBr 30mg), extended-release bi-layer tablets, 2 tablets per pouch (NDC 63824-056-72), OTC, Distributed by Reckitt Benckiser, Parsippany, NJ 07054-0224 Made in England",
      "product_quantity": "155 cases (2000 pouches of 2 tablets per case)",
      "reason_for_recall": "Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch",
      "recall_initiation_date": "20141110",
      "center_classification_date": "20150421",
      "termination_date": "20180330",
      "report_date": "20150429",
      "code_info": "Lot BD375 exp 06/2016; BD566, BD661 exp. 08/2016",
      "more_code_info": ""
    }
  ]
}