CareFusion 213, LLC: Drug Recall

Recall #D-1168-2023 · 08/25/2023

Class II: Risk

Recall Details

Recall Number: D-1168-2023
Classification: Class II
Product Type: Drug
Recalling Firm: CareFusion 213, LLC
Status: Completed
Date Initiated: 08/25/2023
Location: El Paso, TX, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 398,160 cartons

Reason for Recall

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.

Product Description

BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (1 ml) each, 60 applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-31 REF 930480 Product is packaged in the following manner: There is one (1) sterile applicator (sponge) per pouch. Each inner carton contains sixty (60) pouches. There are four (4) inner cartons per shipping case (total of 240 pouches per case).

Distribution Pattern

Distributed nationwide to 100 consignees. Please refer to consignee list.

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 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.
Class I: Dangerous 03/19/2021

Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.

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.