# FDA recall D-0441-2025

> **CareFusion 213, LLC** · Class II · drug recall initiated 2025-05-15.

## Product

BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31.

## Reason for recall

Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.

## Distribution

Nationwide in the U.S.

## Key facts

- **Recall number:** D-0441-2025
- **Recalling firm:** CareFusion 213, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-05-15
- **Report date:** 2025-05-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** El Paso, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0441-2025

## Citation

> AI Analytics. FDA recall D-0441-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0441-2025. Source: US FDA. Licensed CC0.

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