# FDA recall D-0349-2021

> **CareFusion 213, LLC** · Class II · drug recall initiated 2021-03-19.

## Product

ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400

## Reason for recall

CGMP Deviations:  Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.

## Distribution

Distributed Nationwide in the USA and to Singapore, Chile, Oman, Columbia, United Arab Emirates, South Africa, Kuwait, Democratic Republic of the Congo, Qatar, Bahrain, Hong Kong, Brazil.

## Key facts

- **Recall number:** D-0349-2021
- **Recalling firm:** CareFusion 213, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-03-19
- **Report date:** 2021-05-05
- **Termination date:** 2022-09-29

- **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-0349-2021

## Citation

> AI Analytics. FDA recall D-0349-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0349-2021. Source: US FDA. Licensed CC0.

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