# FDA recall D-1148-2023

> **BE PHARMACEUTICALS AG** · Class II · drug recall initiated 2023-09-05.

## 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.

## Reason for recall

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

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1148-2023
- **Recalling firm:** BE PHARMACEUTICALS AG
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-09-05
- **Report date:** 2023-09-20
- **Termination date:** 2025-04-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Zug, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1148-2023

## Citation

> AI Analytics. FDA recall D-1148-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-1148-2023. Source: US FDA. Licensed CC0.

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