CareFusion 213, LLC: Drug Recall

Recall #D-0349-2021 · 03/19/2021

Class II: Risk

Recall Details

Recall Number: D-0349-2021
Classification: Class II
Product Type: Drug
Recalling Firm: CareFusion 213, LLC
Status: Terminated
Date Initiated: 03/19/2021
Location: El Paso, TX, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 40,720,900 cartons

Reason for Recall

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.

Product Description

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, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400

Distribution Pattern

Distributed Nationwide in the USA and to Singapore, Chile, Oman, Columbia, United Arab Emirates, South Africa, Kuwait, Democratic Republic of the Congo, Qatar, Bahrain, Hong Kong, Brazil.

Other Recalls by CareFusion 213, LLC

Class II: Risk 12/17/2025

Lack of Assurance of Sterlity
Class II: Risk 05/15/2025

Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Class I: Dangerous 02/14/2025

Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Class II: Risk 08/25/2023

Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides.
Class I: Dangerous 04/20/2021

Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.

View all recalls by CareFusion 213, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.