ChloraPrep With Tint (CareFusion) – CGMP Deviation (2021)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
CareFusion 213, LLC
Lot Codes / Batch Numbers
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
Products Sold
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;
CareFusion 213, LLC is recalling ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-St due to CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of . This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026