# FDA recall D-0265-2021

> **CareFusion 213, LLC** · Class I · drug recall initiated 2020-07-07.

## 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, 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 to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.

## Distribution

Distributed in Puerto Rico and Oman

## Key facts

- **Recall number:** D-0265-2021
- **Recalling firm:** CareFusion 213, LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-07-07
- **Report date:** 2021-03-03
- **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-0265-2021

## Citation

> AI Analytics. FDA recall D-0265-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0265-2021. Source: US FDA. Licensed CC0.

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