{
  "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": "New York",
      "state": "NY",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA020988"
        ],
        "brand_name": [
          "PROTONIX"
        ],
        "generic_name": [
          "PANTOPRAZOLE SODIUM"
        ],
        "manufacturer_name": [
          "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc."
        ],
        "product_ndc": [
          "0008-0923",
          "0008-4001"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "PANTOPRAZOLE SODIUM"
        ],
        "rxcui": [
          "283669",
          "885257"
        ],
        "spl_id": [
          "a7e7d657-a748-4234-8dd6-c0e4d0f81a86",
          "d36cd2fb-517f-44e5-8438-53e563775f86"
        ],
        "spl_set_id": [
          "51e4144a-489e-436c-609a-39305f8f56ba",
          "f39b3e7d-39d2-4c8a-9974-4ab885241880"
        ],
        "package_ndc": [
          "0008-0923-51",
          "0008-0923-60",
          "0008-0923-55",
          "0008-4001-01",
          "0008-4001-10",
          "0008-4001-25",
          "00008-0941-01",
          "0008-0941-03"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "6871619Q5X"
        ]
      },
      "product_type": "Drugs",
      "event_id": "75871",
      "recalling_firm": "Pfizer Inc.",
      "address_1": "235 East 42nd Street",
      "address_2": "N/A",
      "postal_code": "10017-5703",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0516-2017",
      "product_description": "PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantoprazole per vial, For I.V. infusion only, Rx Only, Distributed by Wyeth Pharmaceuticals Inc, A subsidiary of Pfizer Inc, Philadelphia, PA 19101, Under license from Takeda GmbH, D78467 Konstanz, Germany, MADE IN FRANCE; packaged in A) Pfizer Injectables, 1 vial per carton (NDC 0008-0923-51) in a) bundles of 10 unit cartons (NDC 0008-0923-55) and b) 25 x 40 mg Vials per carton (NDC 0008-0923-60); B) NOVAPLUS, 1 vial per carton (NDC 00008-0941-01) in 25 x 40 mg Vials per carton (NDC 0008-0941-03); and C) PREMIERPro Rx, 1 vial per carton (NDC 0008-4001-01) in a) bundles of 10 unit cartons (NDC 0008-4001-10) and b) 25 x 40 mg Vials per carton (NDC 0008-4001-25).",
      "product_quantity": "582,165 vials",
      "reason_for_recall": "Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.",
      "recall_initiation_date": "20161122",
      "center_classification_date": "20170310",
      "termination_date": "20180622",
      "report_date": "20170322",
      "code_info": "Lot #: A) a) 325449, Exp 12/16; b) N97969, N69175, N69177, Exp 03/17; N95727, Exp 04/17; B) M51076, Exp 11/16; and C) a) 317364, Exp 11/16; b) N73763, Exp 03/17"
    }
  ]
}