{
  "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": "2026-07-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Morristown",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "M027"
        ],
        "brand_name": [
          "MIDOL COMPLETE"
        ],
        "generic_name": [
          "ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE"
        ],
        "manufacturer_name": [
          "Bayer HealthCare LLC."
        ],
        "product_ndc": [
          "0280-8005"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN",
          "CAFFEINE",
          "PYRILAMINE MALEATE"
        ],
        "rxcui": [
          "1597298"
        ],
        "spl_id": [
          "32714ca6-82e9-932c-e063-6394a90ae97d"
        ],
        "spl_set_id": [
          "ce9e6acb-a38b-4c9b-a7e8-3e1c2a49a324"
        ],
        "package_ndc": [
          "0280-8005-16",
          "0280-8005-24",
          "0280-8005-40",
          "0280-8005-01",
          "0280-8005-02",
          "0280-8005-04",
          "0280-8005-25"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0312843555198"
        ],
        "nui": [
          "N0000175739",
          "N0000175729",
          "N0000175790",
          "M0023046"
        ],
        "pharm_class_epc": [
          "Central Nervous System Stimulant [EPC]",
          "Methylxanthine [EPC]"
        ],
        "pharm_class_pe": [
          "Central Nervous System Stimulation [PE]"
        ],
        "pharm_class_cs": [
          "Xanthines [CS]"
        ],
        "unii": [
          "362O9ITL9D",
          "3G6A5W338E",
          "R35D29L3ZA"
        ]
      },
      "product_type": "Drugs",
      "event_id": "61948",
      "recalling_firm": "Bayer Healthcare, LLC",
      "address_1": "36 Columbia Rd",
      "address_2": "",
      "postal_code": "07960-4526",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed to 93 retail accounts/customers.",
      "recall_number": "D-1424-2012",
      "product_description": "Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a) 16 ct. blister (NDC 0280-8005-16), b)24 ct. blister, Distributed by Bayer Health Care, Morristown, NJ 07962 (NDC 0280-8005-25)",
      "product_quantity": "48,528 cartons",
      "reason_for_recall": "Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton.",
      "recall_initiation_date": "20120426",
      "center_classification_date": "20120719",
      "termination_date": "20140327",
      "report_date": "20120725",
      "code_info": "NAA055N Exp.12/13, NAA05PC Exp.12/13, NAA0462 Exp.12/13",
      "more_code_info": ""
    }
  ]
}