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 054

FDA recall notice · announced May 5, 2021 · Carefusion 213

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

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

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.

Notes

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 information: 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; 92469
Quantity: 11,115,774 cartons
Status: Terminated
Products in this recall event:
- BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is (D-0343-2021)
- 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 s (D-0350-2021)
- BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if pa (D-0344-2021)
- BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if pa (D-0348-2021)
- BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is (D-0347-2021)
- 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 s (D-0346-2021)
- 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 p (D-0349-2021)
- 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 p (D-0345-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.