# FDA recall D-0434-2023

> **B. Braun Medical Inc** · Class II · drug recall initiated 2023-03-01.

## Product

Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.Braun Medical Inc, Bethlehem, PA. 18018-3524 USA. NDC 0264-9587-20.

## Reason for recall

Subpotent Drug: low Anti-Factor IIa potency.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0434-2023
- **Recalling firm:** B. Braun Medical Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-03-01
- **Report date:** 2023-03-15
- **Termination date:** 2024-03-13

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0434-2023

## Citation

> AI Analytics. FDA recall D-0434-2023. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/D-0434-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*