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 With Tint Recalled by CareFusion 213, LLC Due to Lack of Assurance of Sterility; Immediate product pouches...

Date: June 13, 2013
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 With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.

Quantity: 23,000 Applicators

Why Was This Recalled?

Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About CareFusion 213, LLC

CareFusion 213, LLC has 29 total recalls tracked by RecallDetector.

Related Recalls

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