{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Zug",
      "state": "",
      "country": "Switzerland",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA216171"
        ],
        "brand_name": [
          "PANTOPRAZOLE SODIUM"
        ],
        "generic_name": [
          "PANTOPRAZOLE SODIUM"
        ],
        "manufacturer_name": [
          "BE Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "71839-122"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "PANTOPRAZOLE SODIUM"
        ],
        "rxcui": [
          "283669"
        ],
        "spl_id": [
          "bad4fab9-654b-423c-87dc-25ff7a9f29d9"
        ],
        "spl_set_id": [
          "52d5bc28-66df-43aa-bb1a-8ac4a2a7f693"
        ],
        "package_ndc": [
          "71839-122-25",
          "71839-122-10",
          "71839-122-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0371839122011"
        ],
        "unii": [
          "6871619Q5X"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92968",
      "recalling_firm": "BE PHARMACEUTICALS AG",
      "address_1": "Bundesstrasse 3",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-1148-2023",
      "product_description": "Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC 71839-122-10; (b) 25 Single-dose vials, NDC 71839-122-25; Rx Only, Mfd. in India for and Distributed by: BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511.",
      "product_quantity": "41,148 vials",
      "reason_for_recall": "Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.",
      "recall_initiation_date": "20230905",
      "center_classification_date": "20230911",
      "termination_date": "20250408",
      "report_date": "20230920",
      "code_info": "Lots: (a) GSC04002A,  GSC04003A, GSC04004A, GSC04006A, Exp Mar-2024; GSC05001A, GSC05006A, GSC05007A, Exp April-2024; GSC10003A, GSC10005A Exp Sep-2024;GSC06004A, GSC06005A, Exp May-2024; GSC07001A,  GSC07007A, GSC07008A, GSC07009A, Exp Jun-2024; GSC08001A, Exp Jul-2024; GSC05009A, Exp Apr-2024;   (b) GSC04005A, Exp Mar-2024; GSC06003A, Exp May-2024; GSC10001A, Exp Sep-2024; GSC07006A,Exp Jun-2024;  GSC08002A, Exp Jul-2024; GSD02012A, Exp Jan-2025; GSD03005A, GSD03008A, Exp Feb-2025;",
      "more_code_info": ""
    }
  ]
}