# FDA recall D-1343-2019

> **B. Braun Medical Inc** · Class II · drug recall initiated 2019-06-13.

## Product

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

## Reason for recall

Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa potency which is intended to ensure that the potency of heparin is within the USP specifications.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1343-2019
- **Recalling firm:** B. Braun Medical Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-06-13
- **Report date:** 2019-06-19
- **Termination date:** 2022-07-15

- **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-1343-2019

## Citation

> AI Analytics. FDA recall D-1343-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1343-2019. Source: US FDA. Licensed CC0.

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