Pantoprazole Sodium Injection, Powder, For Solution
FDA Recall NDC 71839-122
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Pantoprazole Sodium (NDC 71839-122). A significant event, classified as Class II, was initiated on Sep 05, 2023 by Be Pharmaceuticals Inc.. The reported reason for this action was: "Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Sep 05, 2023
Sep 20, 2023
41,148 vials
Recall Profile & Regulatory Data
Event ID
92968
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
BE PHARMACEUTICALS AG
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Apr 08, 2025
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.
Batch or Lot Expiration Information
Lot# 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
Affected Packages Involved in this Recall
71839-122-25Product
71839-122-10Product
71839-122-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
