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FDAFDA · Food and drugs·Recall number D-0345-2021

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

Published May 5, 2021 · Recall initiated: March 19, 2021

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Press Release

Recall details

Manufacturer
CareFusion 213, LLC
Distributor
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
Lot and Exp Date: 0008777, 12/31/2022; 0016325, 12/31/2022; 0021072, 1/31/2023; 0027041, 1/31/2023; 0030959, 1/31/2023; 0031090, 1/31/2023; 0044735, 1/31/2023; 0048062, 2/28/2023; 0052110, 2/28/2023; 0056365, 2/28/2023; 0086148, 2/28/2023; 0104864, 3/31/2023; 0192894, 6/30/2023; 8081571, 3/31/2021; 8086851, 3/31/2021; 8087784, 3/31/2021; 8095620, 3/31/2021; 8106737, 4/30/2021; 8107819, 4/30/2021; 8124917, 4/30/2021; 8130509, 4/30/2021; 8131816, 4/30/2021; 8135646, 5/31/2021; 8141808, 5/31/2021; 8149992, 5/31/2021; 8155991, 5/31/2021; 8162912, 5/31/2021; 8163900, 5/31/2021; 8165721, 6/30/2021; 8176743, 6/30/2021; 8187644, 6/30/2021; 8194993, 6/30/2021; 8199884, 7/31/2021; 8201565, 7/31/2021; 8205560, 7/31/2021; 8206895, 7/31/2021; 8207995, 7/31/2021; 8221939, 7/31/2021; 8228634, 8/31/2021; 8235981, 8/31/2021; 8247508, 8/31/2021; 8264554, 9/30/2021; 8289654, 9/30/2021; 8299615, 10/31/2021; 8304783, 10/31/2021; 8311788, 10/31/2021; 8316776, 10/31/2021; 8332585, 11/30/2021; 8333924, 11/30/2021; 8337646, 11/30/2021; 8337647, 11/30/2021; 8338794, 11/30/2021; 8340914, 11/30/2021; 8352585, 12/31/2021; 8354835, 12/31/2021; 9007921, 12/31/2021; 9015917, 12/31/2021; 9015920, 12/31/2021; 9030934, 1/31/2022; 9043625, 1/31/2022; 9045819, 1/31/2022; 9046572, 2/28/2022; 9052554, 2/28/2022; 9059817, 2/28/2022; 9060734, 2/28/2022; 9071761, 2/28/2022; 9080812, 3/31/2022; 9087980, 3/31/2022; 9087982, 3/31/2022; 9088850, 3/31/2022; 9092575, 3/31/2022; 9100768, 3/31/2022; 9101529, 3/31/2022; 9105675, 3/31/2022; 9113528, 4/30/2022; 9123753, 4/30/2022; 9130718, 4/30/2022; 9133928, 4/30/2022; 9135816, 5/31/2022; 9149671, 5/31/2022; 9150905, 5/31/2022; 9154935, 5/31/2022; 9156866, 5/31/2022; 9165856, 5/31/2022; 9189224, 6/30/2022; 9194257, 6/30/2022; 9196196, 6/30/2022; 9198900, 6/30/2022; 9199815, 6/30/2022; 9200420, 6/30/2022; 9205441, 7/31/2022; 9206555, 7/31/2022; 9233323, 8/31/2022; 9233645, 8/31/2022; 9236531, 8/31/2022; 9238871, 8/31/2022; 9241929, 8/31/2022; 9242192, 8/31/2022; 9246940, 8/31/2022; 9246944, 8/31/2022; 9249460, 8/31/2022; 9251683, 8/31/2022; 9253785, 8/31/2022; 9254193, 8/31/2022; 9255899, 8/31/2022; 9257889, 8/31/2022; 9261886, 9/30/2022; 9266348, 9/30/2022; 9270894, 9/30/2022; 9278673, 9/30/2022; 9280666, 9/30/2022; 9284872, 9/30/2022; 9289666, 9/30/2022; 9291336, 10/31/2022; 9293445, 10/31/2022; 9295140, 10/31/2022; 9297772, 10/31/2022; 9304891, 10/31/2022; 9305777, 10/31/2022; 9311057, 10/31/2022; 9316346, 11/30/2022; 9325127, 11/30/2022; 9326162, 11/30/2022; 9331792, 11/30/2022; 9344775, 11/30/2022; 9345956, 11/30/2022; 9345958, 11/30/2022; 9350617, 12/31/2022; 9352330, 12/31/2022;
Risk classification
Class I
Area (FDA)
drug
Country
United States

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