Skip to content
Recall Observatory FDA recall evidence

Drug product

ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400

D-0267-2021

July 07, 2020

Class I

Product summary

Firm
CareFusion 213, LLC
Event
Event 86998
Status
Terminated
Classification
Class I
Quantity
280 cartons
Official record key
drug-enforcement:D-0267-2021

Official wording

Reason: Microbial Contamination of Non-Sterile Product: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.

Code information: All lots including but not limited to the following lot distributed in Zone IV: Lot # 0192894, Exp. 06/30/2023; 9080812 Exp 03/31/2022

Distribution pattern: Distributed in Puerto Rico and Oman

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination