{
  "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 I",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "MUCINEX FAST-MAX"
        ],
        "generic_name": [
          "ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "RB Health (US) LLC"
        ],
        "product_ndc": [
          "63824-015"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN",
          "DEXTROMETHORPHAN HYDROBROMIDE",
          "GUAIFENESIN",
          "PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1116572"
        ],
        "spl_id": [
          "3cbcc048-bbed-a3e5-e063-6394a90aed10"
        ],
        "spl_set_id": [
          "c902b4fc-c71c-4ef2-b5cb-6c2bd019acbc"
        ],
        "package_ndc": [
          "63824-015-66",
          "63824-015-69"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363824015651"
        ],
        "nui": [
          "N0000193956",
          "N0000008867",
          "N0000009560"
        ],
        "pharm_class_epc": [
          "Expectorant [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Respiratory Secretion Viscosity [PE]",
          "Increased Respiratory Secretions [PE]"
        ],
        "unii": [
          "362O9ITL9D",
          "9D2RTI9KYH",
          "495W7451VQ",
          "04JA59TNSJ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "71013",
      "recalling_firm": "Reckitt Benckiser LLC",
      "address_1": "399 Interpace Pkwy",
      "address_2": "N/A",
      "postal_code": "07054-1133",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1363-2015",
      "product_description": "Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, , Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-015-66, UPC 63824-01565-1",
      "product_quantity": "495036 Bottles",
      "reason_for_recall": "Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.",
      "recall_initiation_date": "20150415",
      "center_classification_date": "20150825",
      "termination_date": "20180309",
      "report_date": "20150902",
      "code_info": "Lot #:           Exp:   MCF0048 7/31/2016  MCF0051 7/31/2016  MCF0052 8/31/2016  MCF0053 8/31/2016  MCF0054 8/31/2016  MCF0055 8/1/2016  MCF0056 8/31/2016  MCF0057 8/31/2016  MCF0058 8/31/2016  MCF0059 10/1/2016  MCF0060 8/31/2016  MCF0061 8/31/2016  MCF0062 8/31/2016  MCF0063 9/30/2016  MCF0064 9/30/2016  MCF0065 9/30/2016  MCF0066 9/30/2016  MCF0067 9/30/2016  MCF0068 9/30/2016  MCF0069 10/31/2016  MCF0070 10/31/2016  MCF0071 10/31/2016  MCF0072 10/31/2016  MCF0073 10/31/2016  MCF0074 10/31/2016  MCF0075 10/31/2016  MCF0076 10/31/2016  MCF0077 10/31/2016"
    }
  ]
}