Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% Recalled by CareFusion 213, LLC Due to CGMP Deviations: Product is being recalled because at...
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) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415
Quantity: 7,990,100 cartons
Why Was This Recalled?
CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About CareFusion 213, LLC
CareFusion 213, LLC has 29 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report