Class II Terminated

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

This recall has been terminated (originally issued May 5, 2021).

Company: Carefusion 213, Llc
Recall Initiated: March 19, 2021
Posted: May 5, 2021
Recall Number: D-0349-2021
Voluntary / Mandated: Voluntary: Firm initiated
Quantity: 40,720,900 cartons
Firm Location: El Paso, TX, United States
Official Source: View on FDA website ↗

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.

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.

Lot / Code Info

Lot and Exp Date: 0000192, 12/31/2022; 0007621, 12/31/2022; 0008775, 12/31/2022; 0009111, 12/31/2022; 0011738, 12/31/2022; 0011753, 12/31/2022; 0011754, 12/31/2022; 0011755, 12/31/2022; 0013604, 12/31/2022; 0015498, 12/31/2022; 0015500, 12/31/2022; 0016329, 1/31/2023; 0017929, 12/31/2022; 0021945, 1/31/2023; 0028887, 1/31/2023; 0031093, 1/31/2023; 0034660, 1/31/2023; 0035149, 1/31/2023; 0036460, 1/31/2023; 0037272, 1/31/2023; 0038213, 1/31/2023; 0038217, 1/31/2023; 0041893, 1/31/2023; 0042483, 1/31/2023; 0042501, 1/31/2023; 0043105, 1/31/2023; 0044739, 1/31/2023; 0094838, 2/28/2023; 0098051, 2/28/2023; 0104859, 3/31/2023; 0129330, 4/30/2023; 0133069, 4/30/2023; 0220728, 7/31/2023; 0223036, 7/31/2023; 8078998, 3/31/2021; 8079620, 3/31/2021; 8079621, 3/31/2021; 8082921, 3/31/2021; 8082923, 3/31/2021; 8085804, 3/31/2021; 8088708, 3/31/2021; 8089621, 3/31/2021; 8093619, 3/31/2021; 8093813, 3/31/2021; 8094833, 3/31/2021; 8096706, 3/31/2021; 8097822, 3/31/2021; 8099727, 3/31/2021; 8099783, 3/31/2021; 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