{
  "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 III",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "4 WAY"
        ],
        "generic_name": [
          "PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Haleon US Holdings LLC"
        ],
        "product_ndc": [
          "0067-2086"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "NASAL"
        ],
        "substance_name": [
          "PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1087043"
        ],
        "spl_id": [
          "43684c76-26b5-24c9-e063-6294a90a9b46"
        ],
        "spl_set_id": [
          "a8fc41c7-4425-41b8-b1c6-eb22ac054734"
        ],
        "package_ndc": [
          "0067-2086-01",
          "0067-2086-05",
          "0067-2086-15"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "04JA59TNSJ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "64533",
      "recalling_firm": "Novartis Consumer Health",
      "address_1": "10401 Hwy 6",
      "address_2": "N/A",
      "postal_code": "68517-9626",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide and Panama",
      "recall_number": "D-209-2013",
      "product_description": "4 way Nasal Decongestant Fast Acting Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2086-05), b) 1-fl. oz. bottles (NDC 0067-2086-01), c) 1.25-fl. oz. bottles (NDC 0067-2086-15), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.",
      "product_quantity": "538,092/.5-fl. oz. bottles,  1,186,740/1-oz. bottles, and  138,528/1.25-fl. oz bottles",
      "reason_for_recall": "Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.",
      "recall_initiation_date": "20130307",
      "center_classification_date": "20130321",
      "termination_date": "20141126",
      "report_date": "20130327",
      "code_info": "Lot #: a) 10108375, 10108376, 10110025, 10110026, 10115487, 10115488, 10120594, 10120595, 10120596, 10120597, 10120753, 10120754, 10120755, 10127564, and 10127567, Exp 4/13 to 11/13, b) 10107916, 10108368, 10108369, 10108370, 10108371, 10108372, 10108373, 10108374, 10110027, 10110028, 10110029, 10110030, 10110031, 10110032, 10110033, 10115803, 10115804, 10115805, 10115806, 10115807, 10115809, 10115810, 10115812, 10115813, 10115814, 10115815, 10120728, 10120737, 10120738, 10120739, 10120740, 10120741, 10120742, 10120743, 10120744, 10120745, 10120746, 10120747, 10120748, 10120749, 10120750, 10120751, 10120752, 10121325, 10127542, 10127543, 10127544, 10127545, 10127546, 10127547, 10127548, 10127549, 10127550, Exp 3/13 to 10/13, c) 10116175, 10117996, 10117997, 10117998, 10117999, 10127535, 10127536, 10127537, 10127538, 10127539, 10127540, and 10127541, Exp 9/13 to 10/13."
    }
  ]
}