{
  "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": "Lincoln",
      "state": "NE",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "THERAFLU"
        ],
        "generic_name": [
          "ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL"
        ],
        "manufacturer_name": [
          "Haleon US Holdings LLC"
        ],
        "product_ndc": [
          "0067-6426"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN",
          "DEXTROMETHORPHAN HYDROBROMIDE",
          "PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1189316"
        ],
        "spl_id": [
          "100acde5-899f-0bed-e063-6294a90aa1a9"
        ],
        "spl_set_id": [
          "a4c56ca0-7785-404b-996d-137cc135f270"
        ],
        "package_ndc": [
          "0067-6426-01",
          "0067-6426-06"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "362O9ITL9D",
          "9D2RTI9KYH",
          "04JA59TNSJ"
        ],
        "upc": [
          "300676426068",
          "300676426013"
        ]
      },
      "product_type": "Drugs",
      "event_id": "65490",
      "recalling_firm": "Novartis Consumer Health",
      "address_1": "10401 Hwy 6",
      "address_2": "",
      "postal_code": "68517-9626",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.",
      "recall_number": "D-752-2014",
      "product_description": "Theraflu Multi-Symptom Severe Cold (acetaminophen 500 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Green Tea & Honey Lemon flavors, packaged in a) 6-count packets per carton (NDC 0067-6426-06, UPC 3 0067-6426-06 8) and b) 1-count packet per card (NDC 0067-6426-01, UPC 3 0067-6426-01 3), Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ  07054-0622.",
      "product_quantity": "1,202,960 cartons and cards",
      "reason_for_recall": "Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.",
      "recall_initiation_date": "20130618",
      "center_classification_date": "20140117",
      "termination_date": "20141104",
      "report_date": "20140129",
      "code_info": "Lot #: a) 10116016, Exp 6/30/2013; 10118931, Exp 7/31/2013; 10121950, Exp 8/31/2013; 10122314, 10122316, 10124226, Exp 9/30/2013; 10124377, 10124379, 10125916, 10128112, 10128114, Exp 10/31/2013; b) 25872801, Exp 7/31/2013",
      "more_code_info": ""
    }
  ]
}