{
  "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": [
          "NDA021359"
        ],
        "brand_name": [
          "RECTIV"
        ],
        "generic_name": [
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        ],
        "manufacturer_name": [
          "Allergan, Inc."
        ],
        "product_ndc": [
          "58914-301"
        ],
        "product_type": [
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        ],
        "route": [
          "RECTAL"
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        "substance_name": [
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        "rxcui": [
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        "spl_id": [
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        "spl_set_id": [
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        "package_ndc": [
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          "58914-301-85"
        ],
        "is_original_packager": [
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        ],
        "nui": [
          "N0000175415",
          "M0014874",
          "N0000009909"
        ],
        "pharm_class_epc": [
          "Nitrate Vasodilator [EPC]"
        ],
        "pharm_class_cs": [
          "Nitrates [CS]"
        ],
        "pharm_class_pe": [
          "Vasodilation [PE]"
        ],
        "unii": [
          "G59M7S0WS3"
        ]
      },
      "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-0419-2021",
      "product_description": "Rectiv (nitroglycerin) Ointment 0.4% For Intra-anal Use Only 30 g Rx Only NDC 58914-301-80 Mfd. by: Pharbil Waltrop GmbH, Im Wirrigen 25, 45731 Waltrop, Germany Distributed by: Aptalis Pharma US, Inc. Birmingham, AL 35242",
      "product_quantity": "31 tubes",
      "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": "2399070"
    }
  ]
}