# FDA recall D-1168-2023

> **CareFusion 213, LLC** · Class II · drug recall initiated 2023-08-25.

## Product

BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (1 ml) each, 60 applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-31 REF 930480  Product is packaged in the following manner: There is one (1) sterile applicator (sponge) per pouch. Each inner carton contains sixty (60) pouches. There are four (4) inner cartons per shipping case (total of 240 pouches per case).

## Reason for recall

Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides.

## Distribution

Distributed nationwide to 100 consignees. Please refer to consignee list.

## Key facts

- **Recall number:** D-1168-2023
- **Recalling firm:** CareFusion 213, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2023-08-25
- **Report date:** 2023-09-27

- **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-1168-2023

## Citation

> AI Analytics. FDA recall D-1168-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-1168-2023. Source: US FDA. Licensed CC0.

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