Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl Recalled by Carefusion 213, Llc Due to Lack of Assurance of Sterility: Firm mistakenly released...

Date: April 23, 2012
Company: Carefusion 213, Llc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Carefusion 213, Llc directly.

Affected Products

ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators, 25 Applicators per Carton, Single Use, Latex Free, Applicator is STERILE if package is intact, NDC 54365-400-01.

Quantity: 576 Cartons

Why Was This Recalled?

Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.

Where Was This Sold?

This product was distributed to 3 states: IL, MO, NJ

Affected (3 states)Not affected

About Carefusion 213, Llc

Carefusion 213, Llc has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report