September 2023 FDA Recall Pantoprazole Sodium by Be Pharmaceuticals Ag
D-1148-2023 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Be Pharmaceuticals Ag on September 5, 2023 for the product Pantoprazole Sodium. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1148-2023

Reason for Recall
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Initiated
09-05-2023
Reported
09-20-2023
Quantity
41,148 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92968
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
BE PHARMACEUTICALS AG
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-08-2025
Product Description About Product Description
Full technical description of the 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.

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

71839-122-25 Pantoprazole Sodium
71839-122-10 Pantoprazole Sodium
71839-122-01 Pantoprazole Sodium