# FDA recall D-1674-2012

> **Carefusion 213, Llc** · Class II · drug recall initiated 2011-11-08.

## Product

ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 260415, Carefusion, Leawood, KS 66211, USA

## Reason for recall

Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1674-2012
- **Recalling firm:** Carefusion 213, Llc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2011-11-08
- **Report date:** 2012-09-26
- **Termination date:** 2013-05-23

- **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-1674-2012

## Citation

> AI Analytics. FDA recall D-1674-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1674-2012. Source: US FDA. Licensed CC0.

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