FDA Recall D-0346-2021

Product

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

Lot / code: Lot and Exp Date: 0011737, 1/31/2023; 0020739, 1/31/2023; 0023790, 1/31/2023; 0037278, 1/31/2023; 0037279, 1/31/2023; 0038209, 1/31/2023; 0044734, 12/31/2022; 0007625, 10/31/2022; 0007630, 12/31/2022; 8095632, 3/31/2021; 8116723, 4/30/2021; 8127657, 4/30/2021; 8135651, 5/31/2021; 8137527, 5/31/2021; 8151741, 5/31/2021; 8158638, 5/31/2021; 8164530, 6/30/2021; 8178658, 6/30/2021; 8193779, 6/30/2021; 8197517, 6/30/2021; 8198765, 7/31/2021; 8212881, 7/31/2021; 8220737, 7/31/2021; 8226561, 7/31/2021; 8235991, 8/31/2021; 8249940, 8/31/2021; 8295569, 10/31/2021; 8304501, 10/31/2021; 8304849, 10/31/2021; 8306694, 10/31/2021; 8311791, 10/31/2021; 8334983, 11/30/2021; 8347719, 11/30/2021; 9008965, 12/31/2021; 9011841, 12/31/2021; 9031893, 1/31/2022; 9037824, 1/31/2022; 9038599, 1/31/2022; 9042938, 1/31/2022; 9044573, 1/31/2022; 9045831, 2/28/2022; 9051563, 2/28/2022; 9052565, 2/28/2022; 9053560, 2/28/2022; 9058847, 2/28/2022; 9059821, 2/28/2022; 9067665, 2/28/2022; 9072856, 2/28/2022; 9086532, 3/31/2022; 9087985, 3/31/2022; 9122538, 4/30/2022; 9126562, 4/30/2022; 9126564, 4/30/2022; 9137903, 5/31/2022; 9137904, 5/31/2022; 9154908, 5/31/2022; 9168975, 6/30/2022; 9171618, 6/30/2022; 9191256, 6/30/2022; 9218464, 7/31/2022; 9218595, 7/31/2022; 9221444, 7/31/2022; 9228305, 8/31/2022; 9241932, 8/31/2022; 9247742, 8/31/2022; 9249471, 8/31/2022; 9257903, 8/31/2022; 9263093, 9/30/2022; 9267133, 9/30/2022; 9269603, 9/30/2022; 9282881, 9/30/2022; 9284875, 9/30/2022; 9284881, 9/30/2022; 9289669, 9/30/2022; 9290455, 10/31/2022; 9291279, 10/31/2022; 9295914, 10/31/2022; 9296395, 10/31/2022; 9305775, 11/30/2022; 9311076, 2/28/2023; 9316348, 10/31/2022; 9317310, 11/30/2022; 9317312, 11/30/2022; 9324565, 11/30/2022; 9337530, 11/30/2022; 9341852, 11/30/2022; 9345911, 11/30/2022; 0098528, 12/31/2022;

Quantity: 6,869,400 cartons

Reason for recall

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.

Recall record

Recall number

D-0346-2021

Classification

Class I

Status

Terminated

Voluntary or mandated

Voluntary: Firm initiated

Firm notification

Press Release

Distribution

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.

Recall initiated

2021-03-19

Classified by FDA Center

2021-04-26

FDA published

2021-05-05

Terminated

2022-09-29

Recalling firm

CareFusion 213, LLC

Firm location

El Paso, TX