D-0350-2021 Class II Terminated

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

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.

Lots and Exp dates: 0009104, 12/31/2022; 0013602, 12/31/2022; 0016431, 1/31/2023; 0022273, 1/31/2023; 0023788, 1/31/2023; 0029135, 1/31/2023; 0032694, 1/31/2023; 0038211, 1/31/2023; 0044741, 1/31/2023; 0064598, 2/28/2023; 0104862, 3/31/2023; 0127010, 4/30/2023; 0196060, 6/30/2023; 0224915, 7/31/2023; 8024958, 1/9/2021; 8025595, 1/31/2021; 8025597, 1/31/2021; 8031857, 1/31/2021; 8033645, 1/31/2021; 8038971, 1/28/2021; 8043969, 1/22/2021; 8043978, 1/31/2021; 8046513, 2/1/2021; 8046721, 1/29/2021; 8053669, 2/28/2021; 8053699, 2/28/2021; 8053947, 2/28/2021; 8055949, 2/28/2021; 8059513, 2/28/2021; 8059562, 2/28/2021; 8061970, 2/19/2021; 8064854, 2/28/2021; 8066666, 2/28/2021; 8068686, 2/28/2021; 8069986, 2/28/2021; 8073868, 2/28/2021; 8087798, 3/31/2021; 8099735, 3/31/2021; 8101641, 3/31/2021; 8106743, 4/30/2021; 8107945, 4/30/2021; 8120678, 4/30/2021; 8122947, 4/30/2021; 8131539, 4/30/2021; 8145833, 5/31/2021; 8155989, 5/31/2021; 8172690, 6/30/2021; 8173860, 6/30/2021; 8191600, 6/30/2021; 8221942, 7/31/2021; 8234936, 8/31/2021; 8243851, 8/31/2021; 8247688, 8/31/2021; 8250928, 8/31/2021; 8253987, 8/31/2021; 8256638, 8/31/2021; 8260782, 8/31/2021; 8265685, 9/30/2021; 8274504, 9/30/2021; 8276704, 9/30/2021; 8282698, 9/30/2021; 8284625, 9/30/2021; 8288853, 9/30/2021; 8338776, 11/30/2021; 8339985, 11/30/2021; 8351538, 12/31/2021; 8355672, 12/31/2021; 9007942, 12/31/2021; 9014571, 12/31/2021; 9017726, 1/31/2022; 9021969, 12/31/2021; 9024576, 1/31/2022; 9030949, 1/31/2022; 9078586, 3/31/2022; 9087987, 3/31/2022; 9092771, 3/31/2022; 9128867, 4/30/2022; 9129671, 4/30/2022; 9135822, 5/31/2022; 9143840, 5/31/2022; 9154907, 5/31/2022; 9154939, 5/31/2022; 9158658, 5/31/2022; 9164579, 5/31/2022; 9175663, 6/30/2022; 9176284, 6/30/2022; 9197931, 6/30/2022; 9199822, 6/30/2022; 9200426, 7/31/2022; 9205380, 7/31/2022; 9207927, 7/31/2022; 9213913, 7/31/2022; 9221459, 7/31/2022; 9224855, 7/31/2022; 9231815, 8/31/2022; 9232764, 8/31/2022; 9233646, 8/31/2022; 9235839, 8/31/2022; 9248040, 8/31/2022; 9261980, 9/30/2022; 9270896, 9/30/2022; 9301763, 10/31/2022; 9310176, 10/31/2022; 9317270, 11/30/2022; 9327966, 11/30/2022; 9327969, 11/30/2022; 9339209, 11/30/2022; 9344806, 11/30/2022; 9345964, 10/31/2022; 9351402, 12/31/2022;