# FDA recall D-004-2013

> **Carefusion 213, Llc** · Class II · drug recall initiated 2012-04-23.

## Product

ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators, 25 Applicators per Carton, Single Use, Latex Free, Applicator is STERILE if package is intact, NDC 54365-400-01.

## Reason for recall

Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.

## Distribution

IL, MO, and NJ

## Key facts

- **Recall number:** D-004-2013
- **Recalling firm:** Carefusion 213, Llc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-04-23
- **Report date:** 2012-10-10
- **Termination date:** 2013-09-11

- **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-004-2013

## Citation

> AI Analytics. FDA recall D-004-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-004-2013. Source: US FDA. Licensed CC0.

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