# FDA recall D-0370-2024

> **B. Braun Medical Inc** · Class II · drug recall initiated 2024-03-06.

## Product

Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-1944-20

## Reason for recall

Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0370-2024
- **Recalling firm:** B. Braun Medical Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-03-06
- **Report date:** 2024-03-20
- **Termination date:** 2025-04-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0370-2024

## Citation

> AI Analytics. FDA recall D-0370-2024. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/D-0370-2024. Source: US FDA. Licensed CC0.

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