Reported Sep 20, 2023 · Terminated

Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose…

Be Pharmaceuticals Ag

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: BE PHARMACEUTICALS AG · Bundesstrasse 3 · Zug · N/A

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 byBE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511

Lot codes and dates: 14 of 14 products
Products covered by this recall
# Product as published
1 (a) GSC04002A, GSC04003A, GSC04004A, GSC04006A, Exp Mar-2024
2 GSC05001A, GSC05006A, GSC05007A, Exp April-2024
3 GSC10003A, GSC10005A Exp Sep-2024
4 GSC06004A, GSC06005A, Exp May-2024
5 GSC07001A, GSC07007A, GSC07008A, GSC07009A, Exp Jun-2024
6 GSC08001A, Exp Jul-2024
7 GSC05009A, Exp Apr-2024
8 (b) GSC04005A, Exp Mar-2024
9 GSC06003A, Exp May-2024
10 GSC10001A, Exp Sep-2024
11 GSC07006A,Exp Jun-2024
12 GSC08002A, Exp Jul-2024
13 GSD02012A, Exp Jan-2025
14 GSD03005A, GSD03008A, Exp Feb-2025
Amount recalled: 41,148 vials

Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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