Pantoprazole Sodium Injection (BE Pharmaceuticals) – Sterility Concern (2023)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
BE PHARMACEUTICALS AG
Lot Codes / Batch Numbers
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
Products Sold
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;
BE PHARMACEUTICALS AG is recalling Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) due to Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026