# FDA recall D-0343-2021

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

## Product

BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-32 REF 930400

## Reason for recall

Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted 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-0343-2021
- **Recalling firm:** CareFusion 213, LLC
- **Classification:** Class I
- **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-0343-2021

## Citation

> AI Analytics. FDA recall D-0343-2021. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/D-0343-2021. Source: US FDA. Licensed CC0.

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