Recalls / Class I

Class ID-0267-2021

Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.

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

Affected lot / code info: 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

Why it was recalled

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.

Recalling firm

Firm: CareFusion 213, LLC
Notification channel: Letter
Type: Voluntary: Firm initiated
Address: 1550 Northwestern Dr, N/A, El Paso, Texas 79912-8000

Distribution

Quantity: 280 cartons
Distribution pattern: Distributed in Puerto Rico and Oman

Timeline

Recall initiated: 2020-07-07
FDA classified: 2021-02-19
Posted by FDA: 2021-03-03
Terminated: 2022-09-29
Status: Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0267-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.