{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Dublin",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "DIPHENHYDRAMINE HYDROCHLORIDE"
        ],
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        "manufacturer_name": [
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        ],
        "product_ndc": [
          "0904-2056",
          "0904-5306",
          "0904-2035"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
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        "substance_name": [
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        ],
        "rxcui": [
          "1020477",
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          "1092422"
        ],
        "spl_id": [
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        "spl_set_id": [
          "04e70311-6412-4a20-84e3-f6e26d5f19ab"
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        "package_ndc": [
          "0904-5306-60",
          "0904-5306-80",
          "0904-5306-61",
          "0904-5306-24",
          "0904-2056-61",
          "0904-2035-24"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "TC2D6JAD40"
        ]
      },
      "product_type": "Drugs",
      "event_id": "87512",
      "recalling_firm": "Cardinal Health Inc.",
      "address_1": "7000 Cardinal Pl",
      "address_2": "N/A",
      "postal_code": "43017-1091",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "FL, GA, SC",
      "recall_number": "D-0512-2021",
      "product_description": "Banophen  Diphenhydramine HCl 25 mg Antihistamine 100 capsules NDC 0904-5306-60 Distributed by: Major Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150 USA",
      "product_quantity": "88 bottles",
      "reason_for_recall": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
      "recall_initiation_date": "20210315",
      "center_classification_date": "20210524",
      "termination_date": "20240617",
      "report_date": "20210602",
      "code_info": "All Lots distributed 02/23/2021 through 03/10/2021"
    }
  ]
}